Clinical Trials

[lunasicc42]

wise, can you call September 09 a "firm" date? So many speculated dates just come and go...

[chesmo]

What about this one?





RNL Bio, cleared to initiate world’s first adult stem cell human trial for spinal cord injury

Korean-FDA approved RNL’s Astrostem based on patient’s own fat derived stem cells to treat spinal cord injury. Phase I human trial will be done by intravenous infusion of stem cells at Sam Hospital in Anyang, South Korea


FOR IMMEDIATE RELEASE
PRLog (Press Release) (http://www.prlog.org/) – Apr 30, 2009 – RNL Bio, global leader in adult stem cell therapeutics, announced on April 30th that the Korean FDA approved its human clinical study to treat patients with spinal cord injury using ‘RNL-Astrostem’ that is based on fat derived adult stem cells.
RNL Bio presented its three years’ preclinical trial results showing perfect safety profile and remarkable efficacy potential. RNL was approved to begin phase I human trial using these adult stem cells and it is the world first trial to treat spinal cord injury with adult stem cells derived patients’ own fat tissue.
RNL-Astrostem is administered by intravenous infusion so patients don’t have to worry about any invasive and painful surgical procedure. Dr. Jeong Chan Ra, CEO of the firm, said “Our stem cell therapeutics involves no immune rejection because the stem cells are exactly patients own. Our adult stem cell has no tumorigenicity activity at all while embryonic stem cell faces high risk of it. We have developed safest therapeutics to help devastated patients with incurable diseases."
RNL Bio already launched commercial stem cell therapy for pets like dogs and cats with spinal cord injury since 2008
# # #
RNL is a premier biotech company in Korea focused on stem cell therapeutics. Headquartered in Seoul with a recently opened state-of-the-art GMP facility, RNL is a publicly traded company on the Korean Stock Exchange (Code 003190)

[topperf]

What about this one?




RNL Bio, cleared to initiate world’s first adult stem cell human trial for spinal cord injury

Korean-FDA approved RNL’s Astrostem based on patient’s own fat derived stem cells to treat spinal cord injury. Phase I human trial will be done by intravenous infusion of stem cells at Sam Hospital in Anyang, South Korea


FOR IMMEDIATE RELEASE
PRLog (Press Release) (http://www.prlog.org/) – Apr 30, 2009 – RNL Bio, global leader in adult stem cell therapeutics, announced on April 30th that the Korean FDA approved its human clinical study to treat patients with spinal cord injury using ‘RNL-Astrostem’ that is based on fat derived adult stem cells.
RNL Bio presented its three years’ preclinical trial results showing perfect safety profile and remarkable efficacy potential. RNL was approved to begin phase I human trial using these adult stem cells and it is the world first trial to treat spinal cord injury with adult stem cells derived patients’ own fat tissue.
RNL-Astrostem is administered by intravenous infusion so patients don’t have to worry about any invasive and painful surgical procedure. Dr. Jeong Chan Ra, CEO of the firm, said “Our stem cell therapeutics involves no immune rejection because the stem cells are exactly patients own. Our adult stem cell has no tumorigenicity activity at all while embryonic stem cell faces high risk of it. We have developed safest therapeutics to help devastated patients with incurable diseases."
RNL Bio already launched commercial stem cell therapy for pets like dogs and cats with spinal cord injury since 2008
# # #
RNL is a premier biotech company in Korea focused on stem cell therapeutics. Headquartered in Seoul with a recently opened state-of-the-art GMP facility, RNL is a publicly traded company on the Korean Stock Exchange (Code 003190)

Looks.... well... do I dare say... good!?

[ChipD]

Not being a pessimist here, but more of a realist. There have been many claims of promising new therapies, especially over these past 5 or so years. But so far none have backed the hype they start with. But things are learned from new therapies, which in turn may help progress other therapies. Unfortunately the best approach for us with SCI’s may be to wait, and watch for more proven well documented therapies. At least it seems that more and more SCI research is being tested and applied over the past 5 years then the 20 years preceding it. Someone may find an answer yet!

[chesmo]

I haven't heard anything about the results from the stem cell therapy for dogs and cats with spinal cord injury launched in 2008. Anyone else? Wise what do you think.

[Leif]

Dr. Wise,
My take is that it is not that simple, as one tends to agree upon, like in an environmental wanting environment. I also from my investigations and from what I’ve heard the cord is a bit more complicated than a few up-down axons. Thus my criticisms is not directed at you, or any, but at some that believes that fixing a chronic cord will be easy and relay on injections. You and all have to understand I have super problems by gaining knowledge over the years on such an approach, too ever happen for the chronic cord. Sure I believe in a cure. No problem, but like explained; we know a lot of the human spinal cord, but what we don’t know is much more. Trial and error might aid, nickels and dimes too, but as for that, what is the difference; poor sci’ed donating money needed to something instead of paying for trials when show up (aside of all this I would have used my money on education, work related I mean). My take on all this dilemma is, researchers don’t do research enough (in general); doc’s fly around and sci’ed don’t care. Whilst, like I have repeatedly argued for there is a solution for all this. But all give a damn and don’t listen. The cure is not a solo race, the cure is going after the money which is there ready for research and usage, but all act like not. I give up.

[Leif]

And time after time this stupid idea occurs that poor spinal cord injured should donate money. This is so wrong and ethically wrong I sometimes want to puke. SCI’ed should not donate. SCI’ed, which by lack of means, should not be trapped into this lost jumbo. Just look at Jim, the founder of a cause of all of this on a Facebook group. Nada money, but an Italian has done better. I personally demand that Jim fraud donate some hard cash. By watching some things here like such things like that, -I give up.

[chesmo]

Here is some info on dogs, cats and horses getting stem cells

http://singularityhub.com/2009/06/25...ment-than-you/ (http://singularityhub.com/2009/06/25/veterinary-stem-cells-why-your-dog-is-getting-better-treatment-than-you/)

[paolocipolla]

And time after time this stupid idea occurs that poor spinal cord injured should donate money. This is so wrong and ethically wrong I sometimes want to puke. SCI’ed should not donate. SCI’ed, which by lack of means, should not be trapped into this lost jumbo. Just look at Jim, the founder of a cause of all of this on a Facebook group. Nada money, but an Italian has done better. I personally demand that Jim fraud donate some hard cash. By watching some things here like such things like that, -I give up.

Leif, you just have to do what you belive is the best thing to do.... then time will tell.... you do what you think is right just like other people do...
But you have to admit that things are progressing toward a cure... and someone is going to get it!

Don't be so negative and nervous, it doesn't help, you know.

[cypresss]

I can say that I really don't know how the facebook groups works when is about raising money, but i can guess. IMO facebook is not enough but Jim is doing a right thing. If we don't care about our cure, why other should pay for our future? We don't have the cure yet. We have to speed up research field. If you don't do research, then put some money there to speed up the process.

I'm a quad and I know that para's can't understand me. More than that, I know that a a lot of able ppl think that when is about paralysis, the walk is the only problem. We all know that is some of the last of our problems. How can we ask to other ppl to care about us, if we don't do something for us? How can we ask researchers to invest their life time to cure us. How can we choose to wait? Is that right? We cannot afford to wait. We have to do something.

If we talk only about this forum, Dr Wise is doing a enormous job for us. How can we thank him? He is going even our neurologists job, and we don't pay him at all. He is a neurologist for world wide ppl with SCI. Imagine your life without informations shared and explained by dr Wise. Have you subscribe(payed subscription) to a medical journal?

I'm not sure, but i think Paulo has donated twice(here I'm talking about the 365$). On facebook he did a good job too invinting others to donate. We have to notice that he is from Europe, but a cure will be for everybody. I don't care about the costs. This cure has to come as soon is possible. Everyone of us has to do something about it. 365$ is not that much especially on western cultures. Ofcorse, others are doing different stuff. I know that Leif is involved in some SCI related action in his country. That's a great thing too.

[cypresss]

In 1987 Dr. Martin Schwab has find a protein that's stops regeneration and in 1993 about the good combination of IN-1 and NT3. The problem is that Dr Martin sold the patent to Regeneron but they never were interested to invest in spinal cord regeneration. For SCI community this is a big lost. We cannot afford this to happen again.

Dr Wise, anyone, do you know others cases like this?

[Wise Young]

In 1987 Dr. Martin Schwab has find a protein that's stops regeneration and in 1993 about the good combination of IN-1 and NT3. The problem is that Dr Martin sold the patent to Regeneron but they never were interested to invest in spinal cord regeneration. For SCI community this is a big lost. We cannot afford this to happen again.

Dr Wise, anyone, do you know others cases like this?

Cypresss, I agree that there are many treatments that have been lost and abandoned due to lack of funding. However, Nogo antibody is not one of them. Let me complete the story which you have correct up to 1993.

In 1990, Martin Schwab discovered that a myelin-associated protein stops regeneration. He developed an antibody, which he called IN-1, that apparently stopped regeneration and hypothesized that his antibody blocked the myelin-associated protein. For a decade, he tried to use IN-1 to isolate the protein but failed. He then used brute force techniques to isolate a protein from myelin that stops regeneration and called this protein nogo. As soon as this was reported, Schwab and three other groups simultaneously cloned the gene that is responsible for Nogo in 2000. In 2001, Strittmatter discovered the receptor to Nogo. That year, Novartis licensed Nogo from Schwab and developed a human antibody against Nogo. They have taken this phase 1 clinical trial with promising results and have initiated phase 2 trials in Europe. It has been applied to dozens of patients. We are all awaiting the results of this trial.

Wise.

[Wise Young]

Great post.


What methods do you guys plan to use to remove the scar tissue, in order for the cells to facilitate across the bridge? You can not pass a bridge if there's a brick wall there, no?

Imight,

If you cut the spinal cord and don't close the dura, fibroblasts invade from the surrounding tissues into the spinal and forms a scar. When this happens, the spinal cord will recognize the non-CNS cells and glial cells will wall off that part of the spinal cord. Yes, a glial scar forms in such a circumstance.

However, this is not what happens in a majority of spinal cord injuries in humans. I have spent a career studying contused spinal cords, the most common form of spinal cord injury in human. When you contuse the spinal cord, there is no penetrating wound and fibroblasts do not enter the spinal cord. There is some gliosis (proliferation of glia) because they repair the blood brain barrier but axons can grow through this area.

In 1997, the Multicenter Animal Spinal Cord Injury Study (MASCIS), a group that I headed, published a paper [1] reporting the histology of 780 rats with contusion injuries and found that 70% of these spinal cords had axons growing into the injury site. We did not transplant into these spinal cords or remove scar. Yet, thousands of axons were able to grow into the injury site.

The scientists who claim that glial scars form and obstruct regeneration all studied models of spinal cord injury that involve cutting the cord. It is like a bunch of blind men feeling an elephant. Those who feel the legs think that the elephant is like a tree trunk. Those who feel the rear think that elephant is like a snake. Those who feel the front think that the animal is a prehensile proboscis.

Wise.


1. Beattie MS, Bresnahan JC, Komon J, Tovar CA, Van Meter M, Anderson DK, Faden AI, Hsu CY, Noble LJ, Salzman S, Young W: Endogenous repair after spinal cord contusion injuries in the rat. Exp Neurol 148:453-463, 1997.

[skeaman]

Wise.[/QUOTE]
They have taken this phase 1 clinical trial with promising results and have initiated phase 2 trials in Europe. It has been applied to dozens of patients. We are all awaiting the results
dr wise when do you think we will see the results and if the results is good will you than go strength to phase 3 hopeful it will not take 2 or 3 years

[Leif]

Nah, you all talk like a bunch that has just robbed a bank. Happy thereafter, but that does not legitimate a bank robbery.

[Leif]

I can say that I really don't know how the facebook groups works when is about raising money, but i can guess. IMO facebook is not enough but Jim is doing a right thing. If we don't care about our cure, why other should pay for our future? We don't have the cure yet. We have to speed up research field. If you don't do research, then put some money there to speed up the process.

I'm a quad and I know that para's can't understand me. More than that, I know that a a lot of able ppl think that when is about paralysis, the walk is the only problem. We all know that is some of the last of our problems. How can we ask to other ppl to care about us, if we don't do something for us? How can we ask researchers to invest their life time to cure us. How can we choose to wait? Is that right? We cannot afford to wait. We have to do something.

If we talk only about this forum, Dr Wise is doing a enormous job for us. How can we thank him? He is going even our neurologists job, and we don't pay him at all. He is a neurologist for world wide ppl with SCI. Imagine your life without informations shared and explained by dr Wise. Have you subscribe(payed subscription) to a medical journal?

I'm not sure, but i think Paulo has donated twice(here I'm talking about the 365$). On facebook he did a good job too invinting others to donate. We have to notice that he is from Europe, but a cure will be for everybody. I don't care about the costs. This cure has to come as soon is possible. Everyone of us has to do something about it. 365$ is not that much especially on western cultures. Ofcorse, others are doing different stuff. I know that Leif is involved in some SCI related action in his country. That's a great thing too.Right, Jim is off, Paolo has done more.

[Leif]

Cypresss, I agree that there are many treatments that have been lost and abandoned due to lack of funding. However, Nogo antibody is not one of them. Let me complete the story which you have correct up to 1993.

In 1990, Martin Schwab discovered that a myelin-associated protein stops regeneration. He developed an antibody, which he called IN-1, that apparently stopped regeneration and hypothesized that his antibody blocked the myelin-associated protein. For a decade, he tried to use IN-1 to isolate the protein but failed. He then used brute force techniques to isolate a protein from myelin that stops regeneration and called this protein nogo. As soon as this was reported, Schwab and three other groups simultaneously cloned the gene that is responsible for Nogo in 2000. In 2001, Strittmatter discovered the receptor to Nogo. That year, Novartis licensed Nogo from Schwab and developed a human antibody against Nogo. They have taken this phase 1 clinical trial with promising results and have initiated phase 2 trials in Europe. It has been applied to dozens of patients. We are all awaiting the results of this trial.

Wise.Pls Wise, not one more word on Nogo.

[Leif]

In 1990, Martin Schwab...
Dr Wise, - we can talk about Schwab until we die. Nothing happens, some just still continues to address this so-called breakthrough, of proteins. You just did it without any hold. My point thus is, why not understand the cord more, by more research? I can’t se you have been too vocal on that. Does that mean we know enough?

[Leif]

We are all awaiting the results of this trial.

Wise. Dr. Wise. We all know this '02 study and trial is dead.

[paolocipolla]

Dr. Wise. We all know this '02 study and trial is dead.

You are wrong, they are starting Phase II

I don't know if the nogo antibody is going to be part of the cure cocktail, you can't tell for sure either.... but for sure the whole study around nogo is contributing to understand better how the spinal cord works. Isn't that what you keep asking for???

BTW Novartis got money for the study from FP7, see proget n°10 (http://cordis.europa.eu/fetch?CALLER=FP7_PROJ_EN&QZ_WEBSRCH=spinal+cord&USR_SORT=EN_QVD+CHAR+DESC)

[Duran]

You are wrong, they are starting Phase II

I don't know if the nogo antibody is going to be part of the cure cocktail, you can't tell for sure either.... but for sure the whole study around nogo is contributing to understand better how the spinal cord works. Isn't that what you keep asking for???

BTW Novartis got money for the study from FP7, see proget n°10 (http://cordis.europa.eu/fetch?CALLER=FP7_PROJ_EN&QZ_WEBSRCH=spinal+cord&USR_SORT=EN_QVD+CHAR+DESC)

Paolo, and is not that shameful if a deep-pocket company like Novartis gets an excessive money while a researcher (Davies, Keirstead) who's working on a real cure for us, goes short of funding?

[Wise Young]

Dr. Wise. We all know this '02 study and trial is dead.

Leif,

They are not only continuing the clinical trial but they published a study recently reporting the promise of the treatment in monkeys http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2695186.



Anti-Nogo-A antibody treatment promotes recovery of manual dexterity after unilateral cervical lesion in adult primates – re-examination and extension of behavioral data
Patrick Freund 1,*, Eric Schmidlin 1,*, Thierry Wannier 1,2,*, Jocelyne Bloch 3 , Anis Mir 4 , Martin E. Schwab 2 and Eric M. Rouiller 1
1 Unit of Physiology and Program in Neurosciences, Department of Medicine, Faculty of Sciences, University of Fribourg, Chemin du Musée 5, CH-1700 Fribourg, Switzerland
2 Brain Research Institute, University of Zürich and Department of Biology, ETH Zurich, Zürich, Switzerland
3 Department of Neurosurgery, Neurosurgery Clinic, University Hospital of Lausanne, Lausanne, Switzerland
4 Neuroscience Research, Novartis Institute for BioMedical Research, Basel, Switzerland

ABSTRACT

In rodents and nonhuman primates subjected to spinal cord lesion, neutralizing the neurite growth inhibitor Nogo-A has been shown to promote regenerative axonal sprouting and functional recovery. The goal of the present report was to re-examine the data on the recovery of the primate manual dexterity using refined behavioral analyses and further statistical assessments, representing secondary outcome measures from the same manual dexterity test. Thirteen adult monkeys were studied; seven received an anti-Nogo-A antibody whereas a control antibody was infused into the other monkeys. Monkeys were trained to perform the modified Brinkman board task requiring opposition of index finger and thumb to grasp food pellets placed in vertically and horizontally oriented slots. Two parameters were quantified before and following spinal cord injury: (i) the standard 'score' as defined by the number of pellets retrieved within 30 s from the two types of slots; (ii) the newly introduced 'contact time' as defined by the duration of digit contact with the food pellet before successful retrieval. After lesion the hand was severely impaired in all monkeys; this was followed by progressive functional recovery. Remarkably, anti-Nogo-A antibody-treated monkeys recovered faster and significantly better than control antibody-treated monkeys, considering both the score for vertical and horizontal slots (Mann–Whitney test: P = 0.05 and 0.035, respectively) and the contact time (P = 0.008 and 0.005, respectively). Detailed analysis of the lesions excluded the possibility that this conclusion may have been caused by differences in lesion properties between the two groups of monkeys.
Received 5 May 2008, revised 22 December 2008, accepted 28 December 2008
European Journal of Neuroscience
Volume 29 Issue 5, Pages 983 - 996

Here is a statement from Martin Schwab:
http://www.axregen.eu/team/university-of-zurich/
In collaboration with research and clinical groups at Novartis, Basel, we are currently conducting a clinical trial with human anti-human antibodies against Nogo-A in acutely injured paraplegic patients. A European and a North American clinical network were founded with the financial help of private foundations in close collaboration with Prof. Volker Dietz and Prof. Armin Curt (Paraplegic Centre, Balgrist, Zurich). Following a large toxicology study in rodents and monkeys conducted by Novartis with us, a Phase I safety study of the anti-Nogo-A antibody trial started in summer 2006. We are currently concluding Phase I. The placebo controlled Phase 2 “proof of concept study” is planned to start in the second half of 2009.

[paolocipolla]

Paolo, and is not that shameful if a deep-pocket company like Novartis gets an excessive money while a researcher (Davies, Keirstead) who's working on a real cure for us, goes short of funding?

Hello Duran,

I am studing how to get money from the FP7 (http://cordis.europa.eu/home_en.html) for SCI research. From what I understand you have to be an expert to apply in the proper way and also it looks to me it is better to have a "polical sponsor" like the RESCUE PROJET (http://www.rescueproject.eu/lire/index.php?cat0=52&rubid=52) did.
So I am not surprised that a company like Novartis (in collaboration with KAROLINSKA INSTITUTET and others) was able to get 3 milions € from the EU.
Researches (from what I know) usually do not have in their staff a person expert of and dedicated to get money in any possible way. A company like Novartis I am sure has many people to do that job.

BTW do you have any experience in that?

[cypresss]

Paolo, and is not that shameful if a deep-pocket company like Novartis gets an excessive money while a researcher (Davies, Keirstead) who's working on a real cure for us, goes short of funding?

IMO, 3million euros is not that much, but I wish to notice one thing: Switzerland is not EU member.

I'm not sure, but i think that any country/researcher(not only those from EU ) can submit for research money. In this case, Davies, Keirstead, Wise and other teams are free to submit. Paolo pls correct me if I'm wrong

As you all know, when is about to take EU money is a lot of work and bureaucracy. Ofcorse there are some companies which have experience and will help you to aces EU money.

[Duran]

Hello Duran,

I am studing how to get money from the FP7 (http://cordis.europa.eu/home_en.html) for SCI research. From what I understand you have to be an expert to apply in the proper way and also it looks to me it is better to have a "polical sponsor" like the RESCUE PROJET (http://www.rescueproject.eu/lire/index.php?cat0=52&rubid=52) did. So I am not surprised that a company like Novartis (in collaboration with KAROLINSKA INSTITUTET and others) was able to get 3 milions € from the EU. Researches (from what I know) usually do not have in their staff a person expert of and dedicated to get money in any possible way. A company like Novartis I am sure has many people to do that job.

BTW do you have any experience in that?

Paolo,

I'm sorry, but you're missing the point. The clinical trials you're talking about have begun in 2006 and so far there's no mention of how the treatment is effective (to what extent). We know that it's safe, even more, any side effects couldn't be seen at high dosages. It has been three years since then. Now, as you may know, this is a single therapy and for acute injuries only (within 14 days). How long will it take until the approach would be tried in combination with stem cells, say for example? And Novartis is a rich company...

What I have noticed, after so many years of looking for a cure, is that the process of getting any therapy through its first phases (I., IIa., IIb.) is so lengthy and nerve-racking that I don't even want to give a thought to where many of us will end up in five years or so if Davies' team (ya know, his approach is amazing) is really going to start doing their trial in two years (the best case scenario)... Shall we be cursing around here yet? I wish I were wrong... but CareCure taught me to be a realist.

[paolocipolla]

IMO, 3million euros is not that much, but I wish to notice one thing: Switzerland is not EU member.

I'm not sure, but i think that any country/researcher(not only those from EU ) can submit for research money. In this case, Davies, Keirstead, Wise and other teams are free to submit. Paolo pls correct me if I'm wrong

As you all know, when is about to take EU money is a lot of work and bureaucracy. Ofcorse there are some companies which have experience and will help you to aces EU money.

Cypresss,

from European commission website (http://cordis.europa.eu/eu-funding-guide/checklist06_en.html) :
"Participation of partners from non-EU countries is also possible under 'Research for the benefit of SMEs' in FP7-Capacities.

In addition, a number of non-EU countries are associated and thus fully participating in FP7 under the same conditions as EU countries. Therefore legal entities established in Switzerland, Israel, Norway, Iceland, Liechtenstein, Turkey, Croatia, the Former Yugoslav Republic of Macedonia, Serbia, Albania or Montenegro are able to receive Community contributions for FP7 contracts/grant agreement"

So an US research group may benefit from EU founding if it estabilish a collaboration with an EU reseach group on a specific project before asking for founding.

Please see the above link, I am just trying to understand the whole thing too.

Paolo

[paolocipolla]

Paolo,

I'm sorry, but you're missing the point. The clinical trials you're talking about have begun in 2006 and so far there's no mention of how the treatment is effective (to what extent). We know that it's safe, even more, any side effects couldn't be seen at high dosages. It has been three years since then. Now, as you may know, this is a single therapy and for acute injuries only (within 14 days). How long will it take until the approach would be tried in combination with stem cells, say for example? And Novartis is a rich company...

What I have noticed, after so many years of looking for a cure, is that the process of getting any therapy through its first phases (I., IIa., IIb.) is so lengthy and nerve-racking that I don't even want to give a thought to where many of us will end up in five years or so if Davies' team (ya know, his approach is amazing) is really going to start doing their trial in two years (the best case scenario)... Shall we be cursing around here yet? I wish I were wrong... but CareCure taught me to be a realist.


A pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty

[dan#3]

dr.wise i'm a t-11 up to t-8 can you see if one of your clinical trial doctors will take me as a subject in your study.thanks dan sheean , i have all my records an ucsf med center will do any follow up when trial is over

[Duran]

A pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty

Good to see you posting it again! It was really missed.

[Wise Young]

dr.wise i'm a t-11 up to t-8 can you see if one of your clinical trial doctors will take me as a subject in your study.thanks dan sheean , i have all my records an ucsf med center will do any follow up when trial is over

Dan#3,

Are you saying that you are currently a T11 neurological level but you were injured at T8? Or where you injured at T11 and you are now at T8?

As soon as the phase 3 trial is approved (it won't be until 2010) and recruitment starts, there will be announcement here and on www.clinicaltrials.gov.


Wise.

[Wise Young]

Paolo,

I'm sorry, but you're missing the point. The clinical trials you're talking about have begun in 2006 and so far there's no mention of how the treatment is effective (to what extent). We know that it's safe, even more, any side effects couldn't be seen at high dosages. It has been three years since then. Now, as you may know, this is a single therapy and for acute injuries only (within 14 days). How long will it take until the approach would be tried in combination with stem cells, say for example? And Novartis is a rich company...

What I have noticed, after so many years of looking for a cure, is that the process of getting any therapy through its first phases (I., IIa., IIb.) is so lengthy and nerve-racking that I don't even want to give a thought to where many of us will end up in five years or so if Davies' team (ya know, his approach is amazing) is really going to start doing their trial in two years (the best case scenario)... Shall we be cursing around here yet? I wish I were wrong... but CareCure taught me to be a realist.

Duran,

Clinical trials do take a long time. To my knowledge, Novartis has started on its phase 2 trials. One of the reasons that it took so long was because Novartis had to make new human antibodies against Nogo and then do studies on monkeys (which are just being published now... I posted the abstract).

Many people don't realize that competition for funds within companies are really intense. Scientists who work with or within companies have to apply for funding for their projects from the company. Internal company committees are probably the ones that are requiring a lot of monkey and safety studies.

I am, however, happy that Novartis is continuing to invest and getting excited about the trial. Please note that other companies have nogo antibodies that are being considered for clinical trials. A little competition may push the trial along faster.

Wise.

[dan#3]

recieved a t-11 burst fracture that turned into an asending eschima to t-8 injurd june 20 2000 somerset el dorado county california.santa clara spinal cord injury rehab didn't catch my injury asending .ucsf said i had secondary swelling that caused it.

[Duran]

Information removed at request of member.

[zoki83]

And time after time this stupid idea occurs that poor spinal cord injured should donate money. This is so wrong and ethically wrong I sometimes want to puke. SCI’ed should not donate. SCI’ed, which by lack of means, should not be trapped into this lost jumbo. Just look at Jim, the founder of a cause of all of this on a Facebook group. Nada money, but an Italian has done better. I personally demand that Jim fraud donate some hard cash. By watching some things here like such things like that, -I give up.

Leif I don't understand how an idea of spinal cord injured people donating is ethically wrong? Nobody is forcing anyone to donate, it is still done by choice. If such a thing were ethically wrong then I suppose when I play poker against someone and loose a hand the other person is ethically wrong because he has taken my money and I have a spinal cord injury. I totally agree with spinal cord injured people donating, I mean if you have the means to donate. As unfortunate as it is, life is simply like that, if you don't look after yourself then nobody else will. You don't need me to tell you that. And for us in the spinal cord injury community, if we don't finally start looking after ourselves then nobody will, as has been shown!

[Johnnie Walked]

Dr. Wise, Do you have heard of the trails of Dr. Xu He has presented in the V.S. trails of a Schwann cell bridge in rats placed gel matrix where nerve fibers and through the growth factors BDNF and NT-3 again on a limited scale grew. But he has now added the growth factor GDNF so much more fiber and Chondroitinase ABC leaving many more nerve fibers grew which made connections with the nerve fibers to the other side of the lesion and long distance grew. Unfortunately he has not given any indication when he expects to be ready for people to try it on.

have you hear of him or his trail ?

Thank`s

[keeping on]

My understanding that the University of Miami Spinal Cord Rehabiltation has and is working with Schwan Cells and Growth Factor ( I'm not sure of what). They have applied, I think, for FDA approval to begin trials using this method. In Talking with them , they have seen 70% success rate, (I'm not sure of kind), in rats. Like I've been saying, rats are being cured all over the world. I only hope our time will come.

[keeping on]

Is there nothing you don't knowabout, Wise? Your indepth knowledge of this mushrooming research is mind booglin and rewarding to the people on this board.

Thank you very much.

[Wise Young]

Dr. Wise, Do you have heard of the trails of Dr. Xu He has presented in the V.S. trails of a Schwann cell bridge in rats placed gel matrix where nerve fibers and through the growth factors BDNF and NT-3 again on a limited scale grew. But he has now added the growth factor GDNF so much more fiber and Chondroitinase ABC leaving many more nerve fibers grew which made connections with the nerve fibers to the other side of the lesion and long distance grew. Unfortunately he has not given any indication when he expects to be ready for people to try it on.

have you hear of him or his trail ?

Thank`s

I answered you at http://sci.rutgers.edu/forum/showthread.php?t=117784

[Wise Young]

My understanding that the University of Miami Spinal Cord Rehabiltation has and is working with Schwan Cells and Growth Factor ( I'm not sure of what). They have applied, I think, for FDA approval to begin trials using this method. In Talking with them , they have seen 70% success rate, (I'm not sure of kind), in rats. Like I've been saying, rats are being cured all over the world. I only hope our time will come.

The Miami Project has spent the last several years developing GMP (Good Manufacturing Practice) certified procedures and facilities to produce Schwann cells from peripheral nerves. They are planning to start clinical trials of Schwann cells. They will need to get FDA permission. It is not easy to get such permission and a lot of work must be done to get the necessary safety data to allow a clinical trial to take place. We are going through the same thing with umbilical cord blood cells.

Wise.

[Johnnie Walked]

Dr. wise thank you verry much of your answer.

Do you know if ChinaSCInet are doing clinical treatments on people like China stem cell company at Shenzhen of is not the same ? en what do you think of this treatments at China stem cell company at Shenzhen are the good ?

[Joshuasmith5873]

Dr. Wise,

I met you last year at the University of Georgia & I hope your well. You mentioned great results in China. Therapy 6 hours a day, 6 days a week for 6 weeks with a 50/50 success with a flush procedure or something. Have there been any improvements ? What is the leading edge procedure with best results for chronic SCI? Most promising?
Thanks,
Joshua Smith

[Johnnie Walked]

Dr. Wise
What is your opinion on this surgical procedure ?

I'm thinking of doing it, because I have a small compression on my spinal canal, (T4-T5 complete) it is not a problem at the moment, but they say I can restore some funtions and improve my quality of life.
I've been injured 6 months, and was never operated because my fracture was stable

What is your opinion on this, please help me !!

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1626077/

http://www.biomedcentral.com/1471-2482/6/12

[Azzurra88]

Dr Young,

How are you? We have chatted on facebook before under a different name, Im the one with the rotty x german shepherd dog as a profile pic and I continually send you poker chips (hope you know who I am) well I'm here in CC to check out the clinical trials we spoke about at the end of last year that you had mentioned will possibly happen in NZ but you weren't sure about Australia, well anyway, I can't find any information here or where it mentions about guniea pigs, can you help me please?

Thanks

Azzurra ; )

[keeping on]

Dr Young, what is the latest on Geron's trial? Also, what is your opinion on how their technology will affect chronic conditions. I understand their trial is for acute cases within 7 days of occurrence.

[Wise Young]

Dr Young, what is the latest on Geron's trial? Also, what is your opinion on how their technology will affect chronic conditions. I understand their trial is for acute cases within 7 days of occurrence.

There is no new information that I am aware of. I am not sure why. I had spoken to company representatives a months ago and they were hopeful that the FDA would allow the trial to go through based on the new data that they submitted last November. Wise.

[keeping on]

Thank you ,Wise. If you learn anything in the future, please let us know.

T.J.

[keeping on]

Wise, Dr Kerr gave a presentation at the Univ of Kentucky. I think it was in 2008. It was in reference to paralyzed rats that his focus was on. He discovered and verified what was needed for reactivation of the nervous system for the rats to respond and then recover and walk. He cleraly was with Johns Hopkins at the time. Do you know what has transpired since on this front, and what his focus is at Biogen?

Thanks in advance,
T.J.

[khmorgan]

In http://www.businessweek.com/magazine/content/10_10/b4169056659487.htm Lilly CEO, John Lechleiter, discusses new techniques (at least for Lilly) to shorten clinical trials.

...
The idea proved its value last year. Instead of completing one trial to determine the best dose for a diabetes drug, then launching a separate trial to determine efficacy, Lilly tested several doses at once. A team of statisticians continuously assessed the data, allowing researchers to eliminate dosages that weren't working. Once the optimal dose was known, researchers continued to test it on the same group of patients, rather than recruiting new ones for a separate phase. Timothy J. Garnett, Lilly's chief medical officer, says this approach could save the company 14 months. ...

[enginerd]

I’m sorry if this is redundant, but I was looking for some updates on the clinical trials. Someone correct me if I am wrong, but the China group is currently looking for participants and that phase two trial is going to start before the phase two trial starts in the USA. Is that trial planned to be completed before the USA trial begins or will they be going on at the same time? Is all the funding secured for the phase two trial in China? If no, how much more is needed? Is all the funding secured for the phase two trial in USA? If no, how much more is needed?

I think it will be easier to get to our financial goals if we can see where we are right now and where we need to be.

[enginerd]

I'm surprised that no one has responded since my last post. No body has this information? When I approach potential donors, should I just say say that we need to raise money? Maybe I'm not looking in the right places on here, but I need to have some more information if I am going to help push the fundraising efforts.

[Fly_Pelican_Fly]

Hey dude. Check out the following sites:

http://www.justadollarplease.org/

& www.chinascinet.org (http://www.chinascinet.org)

and the video on this one has an interview with Wise in it explaining the goings on which is a decent summary.

http://www.ibelieveinc.org/

Im sure Jim will pipe up soon with more useful info

Fly Pelican Fly

[Jim]

Thanks FPF.

Sorry enginerd, didn't see this.

I believe funding has been secured for the China trial. As of last week they were still recruiting patients.

I'm not sure if all the funds have been raised for the SCINetUSA Phase 2 Trial at Brackenridge Hospital in Austin Texas.

The China trial will start, then U.S.



The SCINetUSA Phase 3 Trial is what we are raising money for now. This trial will cost in the neighborhood of $32 million and much of the money will be raised by the participating centers. The JustADollarPlease Campaign is how we hope to raise a great deal of money. We are asking those with SCI and their families and friends to donate $1 dollar per day.

We have completed a new JADP website and will be launching this campaign in the coming weeks.

[Wise Young]

Dr. wise thank you verry much of your answer.

Do you know if ChinaSCInet are doing clinical treatments on people like China stem cell company at Shenzhen of is not the same ? en what do you think of this treatments at China stem cell company at Shenzhen are the good ?

Johnnie, I am so sorry that I did not see your post earlier. ChinaSCINet does clinical trials. We do not charge patients for the treatment. We have nothing to do with the Beike Biotech company in Shenzhen who charges patients for treatments. Wise.

[Wise Young]

I'm surprised that no one has responded since my last post. No body has this information? When I approach potential donors, should I just say say that we need to raise money? Maybe I'm not looking in the right places on here, but I need to have some more information if I am going to help push the fundraising efforts.

Enginerd,

There have been many discussions of the trials being carried out by ChinaSCiNet and SCINetUSA. Many of the trials are still being planned and depend on the result of the ongoing trials.

ChinaSCINet is carrying out five trials. All the trials are and will be announced on http://www.clinicaltrials.gov before they commence.
• CN101. Phase 1 Lithium. This trial was completed in Hong Kong and will soon be published. A total of 20 subjects with chronic spinal cord injury received lithium daily for 6 weeks, after the dose has been titrated produce 0.6-1.0 mM serum lithium levels. The subjects are carefully monitored for any adverse events or damage to their organs, neurological function, neuropathic pain, and spasticity. Although 7 subjects voluntarily dropped out of the trial during the first few weeks, none of these or other subjects had toxic levels (i.e. >1.0 mM serum levels) or any objective evidence of organ damage or neurological changes. We concluded that the treatment is safe. http://www.clinicaltrials.gov/ct2/show/NCT00431171
• CN102A. Phase 2 Lithium. This trial is being carried out in two centers. One center is the China Rehabilitation Research Center (CRRC) where 40 subjects with chronic spinal cord injury were randomized to lithium or placebo. In the lithium group, the dose of lithium was increased every 3 days until subjects had 0.6-1.0 mM serum lithium levels and the treatment was continued for 6 weeks. The subjects were assessed at 6 weeks and 6 months for neurological function, pain (visual analog scale) and spasticity. We found no significant effect of the 6-week lithium treatment on neurological function. Another 20 subjects have been randomized to lithium or placebo in the Tzu Chi Buddhist Hospital in Taichong in Taiwan. In the CRRC trial, subjects in the lithium treatment group unexpectedly had a significant decline in their visual analog pain score at 6 weeks and 6 months. We are now planning a trial to confirm this finding in CRRC and Tzuchi Hospitals in Taiwan.
• CN102B. Phase 2 UCBMC transplants, MP, lithium trial. . This trial assesses safety, feasibility, and efficacy of increasing doses of UCBMC from 1.6, 3.2, and 6.4 million cells, and then the highest "safe" dose of cells plus a bolus dose (30 mg/kg iv) of methylprednisolone (MP) at the time of transplant, and then the highest "safe" dose of the cells plus MP, and a 6-week course of lithium. The trial began in January 2010. The trial will recruit 20 subjects to the study, randomize the subjects to the five treatment groups (4 subjects each). The study is being carried out by the University of Hong Kong and the Chinese University of Hong Kong. Subjects will be assessed closely during the week after the transplant, then 6 weeks, and 6 months later. We are still recruiting subjects for this trial and hope that the treatment phase of the trial can begin in June. http://www.clinicaltrials.gov/ct2/show/NCT01046786
• CN103. Phase 3 UCBMC transplants randomized to lithium or placebo.. This trial will start upon completion of CN102B showing the safe dose of transplant and combination of transplant with methylprednisolone or lithium. Depending on the results of CN102B, we will transplant 1.6, 3.2, or 6.4 million cell dose transplanted into the spinal cord of 400 subjects with chronic spinal cord injury and randomize the subjects to a 6 week course of lithium or placebo. The lithium will be titrated to 0.6-1.0 mM serum levels. The subjects will be followed up at 6 weeks, 6 months, and one year. The rehabilitation protocol is still under discussion.

The SCINetUSA is a clinical trial network in the United States. We are planning four clinical trials.
• US102A. Phase 2 UCBMC plus MP and lithium. This trial is being planned. It will be carried out at the Brackenridge Hospital in Austin, Texas. The goal of the trial is to establish the safety and feasibility of transplanting UCBMC, MP, and lithium to subjects with chronic spinal cord injury, followed by 3-6 months of rehabilitation. This will be in 20 adult subjects (age 17-64).
• US102B. Phase 2 UCBMC plus MP and lithium in older adults. This trial is being planned and will assess the UCBMC plus MP and lithium in 10-20 older subjects (65-80 years old).
• US102C. Phase 2 UCBMC plus MP and lithium in children. We are planning a phase 2 UCBMC plus MP and lithium trial at Shriners Hospital in Philadelphia in children (age 8-17 years old).
• US103. Phase 3 UCBMC, lithium, and locomotor training. We are planning phase 3 trial were 240 subjects are randomized to rehabilitation only, lithium plus rehabilitation, UCBMC plus rehabilitation, and UCBMC plus lithium and rehabilitation.

I must emphasize that the many of the trials are in the planning phase and depend on the results of previous trials and fundraising. As we find out information from the trials, we may plan additional trials.

Wise.

[Johnnie Walked]

Dont worry DOC. You're busy enough

[mcferguson]

Enginerd,

The SCINetUSA is a clinical trial network in the United States. We are planning four clinical trials.
• US102A. Phase 2 UCBMC plus MP and lithium. This trial is being planned. It will be carried out at the Brackenridge Hospital in Austin, Texas. The goal of the trial is to establish the safety and feasibility of transplanting UCBMC, MP, and lithium to subjects with chronic spinal cord injury, followed by 3-6 months of rehabilitation. This will be in 20 adult subjects (age 17-64).
• US103. Phase 3 UCBMC, lithium, and locomotor training. We are planning phase 3 trial were 240 subjects are randomized to rehabilitation only, lithium plus rehabilitation, UCBMC plus rehabilitation, and UCBMC plus lithium and rehabilitation.

I must emphasize that the many of the trials are in the planning phase and depend on the results of previous trials and fundraising. As we find out information from the trials, we may plan additional trials.

Wise.
If I were able to participate in the US102A trial, would that limit my availability for future trials?

[Wise Young]

If I were able to participate in the US102A trial, would that limit my availability for future trials?

Mcferguson, I of course cannot speak for clinical trials that other investigators are carrying out and whether or not they will exclude subjects that have participated in other clinical trials. Participation in our clinical trial may preclude you from other clinical trials. However, I can speak for myself and the trials that I organize. SCINetUSA will be committed to the following principles for people who have already participated in our trials.

1. If a trial shows that one therapeutic arm is effective and the other arms are not, we will do our very best to ensure that people who were randomized to non-effective arms of a trial will receive the effective treatment.

2. We will design and plan clinical trials for those people who have participated in our clinical trial. A therapy may not be the cure for everybody and people are likely to need further therapy.

3. We will tell people who ask what therapy they have received when the trials are over, if the therapy was masked (i.e. double-blind).

Wise.

[Scaper1]

If I may ask, why is the injury level of recruits limited to lower quads and paras? I can guess, but I'm curious about the specific decision for this trial. Thanks!

[Wise Young]

If I may ask, why is the injury level of recruits limited to lower quads and paras? I can guess, but I'm curious about the specific decision for this trial. Thanks!

Scaper1, we will be injecting cells into the spinal cord above and below the injury site. People who have a C4 level would require injection of the cells into the C3 or C4 segment. The phrenic nerve is in that part of the spinal cord and injections of cells into this part of the spinal cord may compromise respiration.

We are planning a trial for high quads (C1-C4) if the current trials show beneficial effects but modify the procedure so that the cells are injected into the injury site and on the caudal edge of the injury site. I think that this would be safer.

Wise.

[DA]

Scaper1, we will be injecting cells into the spinal cord above and below the injury site. People who have a C4 level would require injection of the cells into the C3 or C4 segment. The phrenic nerve is in that part of the spinal cord and injections of cells into this part of the spinal cord may compromise respiration.

We are planning a trial for high quads (C1-C4) if the current trials show beneficial effects but modify the procedure so that the cells are injected into the injury site and on the caudal edge of the injury site. I think that this would be safer.

Wise.

what do you hope to accomplish?

[ineedmyelin]

Scaper1, we will be injecting cells into the spinal cord above and below the injury site. People who have a C4 level would require injection of the cells into the C3 or C4 segment. The phrenic nerve is in that part of the spinal cord and injections of cells into this part of the spinal cord may compromise respiration.

We are planning a trial for high quads (C1-C4) if the current trials show beneficial effects but modify the procedure so that the cells are injected into the injury site and on the caudal edge of the injury site. I think that this would be safer.

Wise.

would you accept a c4c5 incomplete walking quad?

[Azzurra88]

Just wondering are there any trials coming to Australia or New Zealand, details would be greatly appreciated on behalf of a c3/c4 quad... ; )

[mcferguson]

Mcferguson, I of course cannot speak for clinical trials that other investigators are carrying out and whether or not they will exclude subjects that have participated in other clinical trials. Participation in our clinical trial may preclude you from other clinical trials. However, I can speak for myself and the trials that I organize. SCINetUSA will be committed to the following principles for people who have already participated in our trials.

1. If a trial shows that one therapeutic arm is effective and the other arms are not, we will do our very best to ensure that people who were randomized to non-effective arms of a trial will receive the effective treatment.

2. We will design and plan clinical trials for those people who have participated in our clinical trial. A therapy may not be the cure for everybody and people are likely to need further therapy.

3. We will tell people who ask what therapy they have received when the trials are over, if the therapy was masked (i.e. double-blind).

Wise.
Thanks. That's good to know. I'll be saving up my vacation and sick time.

[Wise Young]

what do you hope to accomplish?

In the CN102B phase 2 trial being conducted in Hong Kong now, we are randomizing patients to five treatment groups, receiving 1.6, 3.2, or 6.4 million umbilical cord blood mononuclear cells (UCBMC), the highest "safe" dose of cells plus a bolus dose of methylprednisolone which improves survival of the cells, and that dose plus methylprednisolone and a 6-week course of lithium which we expect to cause the transplanted cells to proliferate in the spinal cord. If our hypothesis is correct, the escalating doses should not only be safe but should be associated with increasing function improvements in the patients. If so, we will proceed to CN103 in China, which will randomize 400 patients transplanted with UCBMC to a 6-week course of placebo or lithium.

Depending on the results of the CN102B, we may proceed with US102A, which would be carried out in the Brackenridge Hospital in Austin, TX. This trial would assess the feasibility of doing the procedure in the U.S. This would be followed by US103, the phase 3 trial to establish efficacy,

Wise

[keeping on]

Wise, sounds good to me. We're counting on ya.

[DA]

In the CN102B phase 2 trial being conducted in Hong Kong now, we are randomizing patients to five treatment groups, receiving 1.6, 3.2, or 6.4 million umbilical cord blood mononuclear cells (UCBMC), the highest "safe" dose of cells plus a bolus dose of methylprednisolone which improves survival of the cells, and that dose plus methylprednisolone and a 6-week course of lithium which we expect to cause the transplanted cells to proliferate in the spinal cord. If our hypothesis is correct, the escalating doses should not only be safe but should be associated with increasing function improvements in the patients. If so, we will proceed to CN103 in China, which will randomize 400 patients transplanted with UCBMC to a 6-week course of placebo or lithium.

Depending on the results of the CN102B, we may proceed with US102A, which would be carried out in the Brackenridge Hospital in Austin, TX. This trial would assess the feasibility of doing the procedure in the U.S. This would be followed by US103, the phase 3 trial to establish efficacy,

Wisehow much functional improvement are you thinking is possible?
you told me you didnt know in austin, but c'mon, right or wrong you have to have an idea of what you think can happen.

[keeping on]

DA, Imust say that my recall of Wise expects is:

1. restoration of bowel and bladder control
2. REstoration of sexual function
3. Restoration of balance
4. Restoration fo walking

These are what I got from previous posts; all the talk of going from 1 to 3 are not as improtant as functional restoration in real terms.

[enginerd]

Thanks for all the information! I will continue my efforts of raising some funds. We just need to get those China trials started. I'm surprised they are having difficulties rounding up some volunteers...I guess that just buys me some time to do my thing.

Peace.

[DA]

DA, Imust say that my recall of Wise expects is:

1. restoration of bowel and bladder control
2. REstoration of sexual function
3. Restoration of balance
4. Restoration fo walking

These are what I got from previous posts; all the talk of going from 1 to 3 are not as improtant as functional restoration in real terms.

he also said the trial doesn't address every problem needed for cord regeneration so
i dont understand how that is possible in a complete injury. he said it on the forum and he said it in person.

my understanding of the trial is once complete, another therapy will be added. then start over with clinical trials. once complete, then add another therapy, then start trials all over again. once complete, then add the final therapy, start trials again.

[lakboy]

DA, Imust say that my recall of Wise expects is:

1. restoration of bowel and bladder control
2. REstoration of sexual function
3. Restoration of balance
4. Restoration fo walking

These are what I got from previous posts; all the talk of going from 1 to 3 are not as improtant as functional restoration in real terms.

What else is left , my dear friend ? Lol

[keeping on]

Just saying what the therapy, if successful, is to bring. Carry on , my friend, carry on.

[Schmeky]

]DA, Imust say that my recall of Wise expects is:

1. restoration of bowel and bladder control
2. REstoration of sexual function
3. Restoration of balance
4. Restoration fo walking


With all due respect, this must be in error. I'm not aware of anything that will provide this level of recovery. I think Wise Young probably meant he would like to see this level of recovery.

[keeping on]

This is what I saw of a response from Wise. Things won't be perfect, but improvement in all area will be accepted. If we can reattach nerves and are willing to work at rehab as Wise suggets; why not work to this end. We have to keep looking for towards the future and all the possibilites that are bieng shown in research.

[keeping on]

Schmecky Go to the thread " Ten Frequently Asked Questions and go to the beginning statement by Wise from 2004. When I asked whether these statements were still in effect or to be changed, Wise's reply was not at this time. that's what these upcoming therapies are supposed to do.

[Johnnie Walked]

Dr. Young

We're in june, half of 2010 en nothing happens jet !! WHATS UP ?? 4,5 Years more too go, and another 5 years pass

Start the show please one's and voor all !!!

[lunasicc42]

Once and for all?

[keeping on]

Johnnie and lunasicc, we all agree and waiting impatiently for Wise to speak and get us going. I'm hoping our time is now.

keeping on

[Schmeky]

Johnnie Walker,

This sh_ts been goin' on for the last 9 years I'm aware of, wait, I forgot, it's only 5 more years away :)

Keeping on,

I love your enthusiasm, but the clinical trial process in the USA will ensure your "senior" membership on this forum. So make certain you have a comfortable cushion and do those pressure reliefs.

[mv740]

Johnnie Walker,

This sh_ts been goin' on for the last 9 years I'm aware of, wait, I forgot, it's only 5 more years away :)

Keeping on,

I love your enthusiasm, but the clinical trial process in the USA will ensure your "senior" membership on this forum. So make certain you have a comfortable cushion and do those pressure reliefs.

schmeku, you are so pathetic. i cant believe how a man can get so low. how old are you?? i mean the only thing you do is being negative. nobody gives a fuck how long you have heard that the cure is 5 years away. you r very stupid. i guess it makes yurself less miserable by trying to take away hope from others. start living your lifeand dont feel so sorry about yourself

[Schmeky]

mv740,

I don't normally fire back, but I'll make an exception just for you, and just once. Here ya go Mr. F_ckin' know it all:

1. The average time for a drug to go from discovery to market is 11.4 years. By the way, this is not an "official number". Several years ago, I did a study of all the drugs approved by the FDA in the 1990's. I looked up the first paper reporting efficacy of the treatment for the given condition, using that as the "discovery date". The range was 5-18 years. Of course, this analysis included only drugs that successfully made it through to FDA approval. Many drugs don't make it at all.

2. Minimum time for a testing new treatment from scratch after discovery. Minimum time for preclinical and clinical trials after discovery is 7 years. Assuming that there is sufficient funds and there are no delays due to lack of funding, preclinical trials take two years to complete, phase 1 trials should take a year, phase 2 trials two years, phase 3 trials two years. Two phase 3 trials are required by the FDA and they are often carried out in parallel. This takes a minimum of 7 years.

[jim sampson]

schmeky,
we are seeing first hand the morons being created by legalized dope in denmark.he is an idiot dont waste your energy on this simpleton.

[Wise Young]

Guys, please stop. There is no point to this discussion.

Many people with spinal cord injury are members of a club that they did not want to join. Unfortunately, there is no easy way out. For some who have incomplete spinal cord injury, intensive training can restore substantial function, including locomotion. However, for those who have severe injuries, exercise alone is not sufficient. Therapies are necessary for recovery for some people.

Many therapies have been reported to make animals walk and to stimulate regeneration of the spinal cord. These therapies are keys to the lock. There are lots of keys in the keychain but only a few have been used to see if they would open up the lock. Clinical trials are attempts to use the keys to open the locks. Presumably the best keys are being chosen.

Many people have theories concerning which keys are best. Clearly, the more keys we have and the more times the keys are tried, the greater the likelihood of success. Each trial has a probability of success and also will provide information concerning which keys are most likely to succeed. Therefore, the more trials, the greater the likelihood of success.

The concept that it may take x years to open the lock is irrelevant for the following reasons. First, if we don't try, the lock will never be opened. Second, time is a matter of resources and effort. If we have 1000 clinical trials going and each clinical trial takes 2 years, this means that we are very likely to find a therapy that works in 2 years. If we do 1000 trials in sequence, it may take 2000 years.

If you have given up on the cure, that is your right. However, it is not right to obstruct the effort to attain a cure by repeatedly claiming that it is impossible. In my opinion, claims that there will never be effective therapies of spinal cord injury are wrong. Even if it doesn't come within your lifetime, please don't be so selfish as to deny it to others and future generations.

On the other side, if you disagree with somebody's pessimistic view, don't call them names. Come up with reasons why they are wrong. They will be glad to be wrong. You can make the argument without getting personal or calling names. Name-calling just stops the discussion. So, please, no more attacks of each other.

Wise.

[donz]

schmeku, you are so pathetic...
Ummmm

[Buck503]

Many therapies have been reported to make animals walk and to stimulate regeneration of the spinal cord. These therapies are keys to the lock.

You're right. There is no end to the success in animal models.
A friend of mine recently said during a discussion about Geron
that "it must feel like they're dangling a cure in front of you."

People need to stop taking every breakthrough so seriously.


If we have 1000 clinical trials going and each clinical trial takes 2 years, this means that we are very likely to find a therapy that works in 2 years. If we do 1000 trials in sequence, it may take 2000 years.

What are the odds of that? Especially in this economy. We're
fortunate for your effort, since it's the only serious one at this
point.

[alipur]

http://betahealtblog.co.cc/1072.php

[Wise Young]

You're right. There is no end to the success in animal models.
A friend of mine recently said during a discussion about Geron
that "it must feel like they're dangling a cure in front of you."

People need to stop taking every breakthrough so seriously.



What are the odds of that? Especially in this economy. We're
fortunate for your effort, since it's the only serious one at this
point.

Buck, I agree with you. People should stop taking every "breakthrough" so seriously. A "breakthrough" is only a step in the right direction and not itself the cure. But people should also not be saying with every animal or clinical study showing encouraging results that no therapy will ever become available.

I also agree that the odds of having many clinical trials in this economy is low. However, I believe that it can happen if the community funds the effort itself. The http://JustADollarPlease.Org campaign is how it can be done, despite the economy. If 100,000 families with spinal cord injury each donated a dollar a day, this would add up to $36.5 million per year, enough to fund several trials per year.

By the way, 1000 clinical trials at a time is not that impossible. There are now over 200 clinical trials of different MS therapies. In cancer, there are over 1000 clinical trials. Almost everybody that has cancer is being considered for some kind of clinical trial testing the most promising experimental therapy against the best standard therapy.

The first time that anything new and important has been been done, there were always naysayers who said that it has never been done before and that it cannot be done. Most of the time, they are right. But, sometimes they are wrong. Every major discovery went through this gauntlet.

When I started ChinaSCINet, people told me that it is not possible to form a clinical trial network in China. There has never been a clinical trial network in China before and Chinese doctors have never voluntarily worked before to do clinical trials together. Where would we raise the money, etc., etc.?

Well, we have formed such a network. Now, the network has to do its job and test therapies. Scientists in the laboratories must provide therapies and the network must try these therapies on patients. By the way, there are enough patients in China to do test 1000 therapies.

Please understand that the network will take us into directions that we never anticipated. Indeed, some of the results have been completely unanticipated. For example, the discovery that intradural decompression improves locomotor recovery is a surprise. Likewise, we did not expect lithium to reduce neuropathic pain. These findings must be confirmed.

Finally, I hope that we get enough funding and support to complete the planned trials on umbilical cord blood plus lithium. If cord blood mononuclear cells don't work, we need to know it and move on. If they do work, then that would be great. If we don't try, we will never know.

Wise.

[dukevanwillem]

No doubt what Wise says about the time line from clinical trial to clinical practice is true, but there are some exceptions. I have heard that there is a fast track process for certain special cases. Obviously safety must be ensured. But there may be an even faster back door via countries with less glacial approval processes. That is, once a treatment is demonstrated to be effective, a lot of doctors around the world will be happy to make a nickel off it. This must happen a lot, especially when the treatment does not involve a patent.

This is all the more reason to contribute to justadollarplease. The process doesn't begin until human trials prove something effective.

I guess this is all old hat to many of those on this forum, but I thought it bore repeating because of recent posts.

[Brent A]

Guys, please stop. There is no point to this discussion.

Many people with spinal cord injury are members of a club that they did not want to join. Unfortunately, there is no easy way out. For some who have incomplete spinal cord injury, intensive training can restore substantial function, including locomotion. However, for those who have severe injuries, exercise alone is not sufficient. Therapies are necessary for recovery for some people.

Many therapies have been reported to make animals walk and to stimulate regeneration of the spinal cord. These therapies are keys to the lock. There are lots of keys in the keychain but only a few have been used to see if they would open up the lock. Clinical trials are attempts to use the keys to open the locks. Presumably the best keys are being chosen.

Many people have theories concerning which keys are best. Clearly, the more keys we have and the more times the keys are tried, the greater the likelihood of success. Each trial has a probability of success and also will provide information concerning which keys are most likely to succeed. Therefore, the more trials, the greater the likelihood of success.

The concept that it may take x years to open the lock is irrelevant for the following reasons. First, if we don't try, the lock will never be opened. Second, time is a matter of resources and effort. If we have 1000 clinical trials going and each clinical trial takes 2 years, this means that we are very likely to find a therapy that works in 2 years. If we do 1000 trials in sequence, it may take 2000 years.

If you have given up on the cure, that is your right. However, it is not right to obstruct the effort to attain a cure by repeatedly claiming that it is impossible. In my opinion, claims that there will never be effective therapies of spinal cord injury are wrong. Even if it doesn't come within your lifetime, please don't be so selfish as to deny it to others and future generations.

On the other side, if you disagree with somebody's pessimistic view, don't call them names. Come up with reasons why they are wrong. They will be glad to be wrong. You can make the argument without getting personal or calling names. Name-calling just stops the discussion. So, please, no more attacks of each other.

Wise.
Dr. Young,
I couldnt agree with you more. I am only 2.5 years out from my injury, but I will ALWAYS keep hope alive. I work out daily and have seen lots of progress, but then ive gone a long time with NO progress, but I will never give up on hope. I am confident that one day we will find a cure, NO MATTER HOW LONG IT MAY TAKE, I will work everyday and stay strong for when that cure comes. We must stay focused and realize it is a marathon, not a sprint. You have dedicated your life, and many other scientist have done the same to help those like me out! I am forever grateful for your efforts in finding a cure.
It took Thomas Edison, 1,000's of tries before he invented the light bulb. When asked why he continued after all the failures, he said. "I didn't fail, I just found 1,000's of ways how NOT to make a light bulb" It only takes 1 success to change history! I firmly believe success is in your future Dr. Young! You will always have my support!

[keeping on]

Brent, amny of us share your view. What else can we do. I exewrcise everyday with little or no improvement. I, and we, all wait for some tangible news form clinical trials. Let's hope Wise will get his started. Wise, I must disagree with your assesment of our committment. To say that we should be satisfied with future generations to beneift from these therpies. and we should be satisfied with that. that's not correct. Yes, if we can benefit future generations by being the first ones to go thru trials, that is good. But don't lead us on and forget about us. I'mnot and I'm sure many of us are not!!1

[Schmeky]

I want to apologize for my post #330 to mv740. I crossed the line. I am sorry to mv740 and the forum. I should know better. I was having a bad day; a really bad day.

It happens.

Dr. Young is correct, we have to work, try, push. Clinical trials, no matter how long they take (or don't), are the key.

I respectfully request a moderator delete the bad word in my post #330.

[pawel tabakow]

Dear patients,


Our group from the Department of Neurosurgery Wroclaw Medical University (Poland) has worked since 2004 on a trial evaluating the safety and feasibility of transplantation of human olfactory ensheathing cells in patients with complete (ASIA A) thoracic spinal cord injuries. We performed in 2008 the first two operations. Results from an 1.5-year-observation of both operated patients show that OEC grafting was a safe procedure. Besides, both patients improved neurologically: the first from ASIA A to ASIA C and the second from ASIA A to ASIA B. There is some evidence from radiological and neurophysiological studies that may suggest regeneration of long fiber tract in the spinal cords of those patients. No from the patients from the control group (non-operated) has showed any improvement within the one year observational period.

On June 17 2010 , we performed a third operation. A 26- jear old man with complete thoracic spinal cord injuty at level Th4 underwent transplantation of autogenous olfactory ensheathing cells, obtained from his olfactory mucosa. His general and neurological state is stable at this moment and will be followed in the next 2 years.

I would like to point out that final estimation of the safety and effectiveness of our procedure requires longer observations and the conduction of the procedure in more patients.

Best wishes,

dr Pawel Tabakow MD, PhD

Associate Professor

Department of Neurosurgery Wroclaw Medical University

Poland

[Susqu]

Sounds great for the safety determiation!

My only question, as far as effetiveness, is whether the 2 patients were acute injuries or cronic ones.

Will be interested to learn more.

[pawel tabakow]

All operated three patients have sustained a chronic spinal cord injury of the thoracic spinal cord at vertebral levels Th10/11 (patient that underwent spinal cord transection, teated 4 years after injury), Th6/7 (patient with a compression injury, treated 5 years after injury) and Th4 (patient with a compression injury, treated 1.4 years after injury)

dr Pawel Tabakow

[Leif]

All operated three patients have sustained a chronic spinal cord injury of the thoracic spinal cord at vertebral levels Th10/11 (patient that underwent spinal cord transection, teated 4 years after injury), Th6/7 (patient with a compression injury, treated 5 years after injury) and Th4 (patient with a compression injury, treated 1.4 years after injury)

dr Pawel TabakowHi, My Q is, given the very few lab's actually focusing on sci and the different cord levels involved, - how to make a outcome-instrumental high theck trial out of that, as for gains, and in a study, -say in Europe (and US). Thanks upfront.

dr. erick the red.

[hp]

Hi, My Q is, given the very few lab's actually focusing on sci and the different cord levels involved, - how to make a outcome-instrumental high theck trial out of that, as for gains, and in a study, -say in Europe (and US). Thanks upfront.

dr. erick the red.

Leif, I am not Dr. Tabakov but could you clear you question or make it easier to understand just for me.

[e.t.]

Leif, I am not Dr. Tabakov but could you clear you question or make it easier to understand just for me.

Leif said, that lack of tech. equipment in Norway blocks clinical trial.

[pulaski]

Thank you dr. Tabakow.
You are doing a greate job. We need more such researchers and more such clinical trial.
Thank you again.
Please for further information.

[rexio]

Dr.Tabakow during the conference which took place the morning after the latest surgery. This conference was held in Wroclaw's Medical University.

[e.t.]

Hello Leif.
How do you feel?

[Leo]

Thank you dr. Tabakow.
You are doing a greate job. We need more such researchers and more such clinical trial.
Thank you again.
Please for further information.

Yes Thank you very much.

Was decompression surgery done on these patients before treatment?

Also do you have near future plans for combination treatment?

Again, Thank you

[keeping on]

Wise, any update on Hong King trial? Please make it happen.

keeping on

[CAS]

The first time that anything new and important has been been done, there were always naysayers who said that it has never been done before and that it cannot be done. Most of the time, they are right. But, sometimes they are wrong. Every major discovery went through this gauntlet.

Wise.

To Dr Wise

I would like to disagree with your assessment of naysayers they are in most cases wrong 90% of the time and I do love seeing them having their Back sides kicked.

otherwise nothing would be done in any field as it would appear hopless. Although i think we do need Government involvement in aeras that the commercial adventure of a project do's not appear fesiable at this point of time, or at any other time. The likes of commercial space development is comming to the front on the knowledge from what NASA and others have done in the past decades. ( i know different topic but the samne principle)
:mega:

[Wise Young]

Wise, any update on Hong King trial? Please make it happen.

keeping on

Keeping on,

There is no new news. Please be patient. I have instituted changes and they are being implemented.

Wise.

[keeping on]

Wise, we need the trials to start. Please give updates when you get your candidates in place. Please let us know . What are the changes you mentioned and why? Please keep us abreast.

keeping on

[0xSquidy]

Keeping on!! :)
If i could only turn all that energy of yours into something more productive. You should come here to Spain and work in my foundation, you are like a nuclear weapon with wheels.

[Donnie]

Keeping on!! :)
If i could only turn all that energy of yours into something more productive. You should come here to Spain and work in my foundation, you are like a nuclear weapon with wheels.

lol... So true!!

[keeping on]

Ox, rather proacttive vs nuclear reactive. We, as a group must be proactive and look to the future. I love all and want all to have a chance. We can get this thing started. Wise needs to keep us abreast of Hong Kong trials and get them going.

keeping on

[0xSquidy]

I agree keeping on but maybe carecure's forum is not where we should push. We have to push in the real world where we can make a change. Wise's already pushing like hell.

Take care.

[keeping on]

Ox, we'r enot oposing Wise. We're with him and we, you and I must push for something to happen. There is going to be a groundswell of improvements for all these people. Wise is leading the way; we're saying time is the of the essence. Remeber, Wise might be pushinglike hell; what the hell do you think you and I ARE DOING? It's going to happen!!!

[Johnnie Walked]

Ox, we'r enot oposing Wise. We're with him and we, you and I must push for something to happen. There is going to be a groundswell of improvements for all these people. Wise is leading the way; we're saying time is the of the essence. Remeber, Wise might be pushinglike hell; what the hell do you think you and I ARE DOING? It's going to happen!!!

He is not 100%

[keeping on]

Good new for cerebral palsey patients; first stem cell therapy for patients doesn't cure, but improves life.http://www.google.com/url?sa=t&source=web&cd=1&ved=0CCYQqQIwAA&url=http%3A%2F%2Fwww.marketwatch.com%2Fstory%2Fint ernational-stem-cell-institute-launches-customized-stem-cell-therapy-treatments-for-cerebral-palsy-2010-07-13%3Freflink%3DMW_news_stmp&ei=QK08TPTvGoH-8AaYp6ynBg&usg=AFQjCNGnQSC7f6wkKO1LvtGkDpFxHhV2LQ; sorry, best I can do.

keeping on

[Mike Bussolari]

Have the people at SCInetUSA or anyone anywhere tried to start a text messaging fundraising campaign like they did for Haiti relief?

[Mike Bussolari]

http://www.mobilecommons.com/organizations/fundraising/
(http://www.mobilecommons.com/organizations/fundraising/)

you have to be a nonprofit organization to do it, otherwise I would have already.

Everyone including us is so lazy that it's perfect.

[Buck503]

http://www.mobilecommons.com/organizations/fundraising/
(http://www.mobilecommons.com/organizations/fundraising/)

you have to be a nonprofit organization to do it, otherwise I would have already.

Everyone including us is so lazy that it's perfect.

Great idea! This is so much more convenient. People would probably
be more inclined to contribute if they could just text something like
'curesci' to donate money.

[SharonD]

that is a great idea....I will bring it up at the meeting next Thursday, after the open house Dr Young has asked those interested in fundraising to stick around

[0xSquidy]

I'm setting up my foundation here in Spain. It's quite difficult if you have similar laws in this matter, but it's totally doable and we have to do something about all this mess.

Never give up.

[KIM]

Ox
You could start supporting Dr. Vaquero I think he must not be too far from the moneys he might need.

[0xSquidy]

Ox
You could start supporting Dr. Vaquero I think he must not be too far from the moneys he might need.

KIM: I can't wait to help Vaquero's work :) We're studying it but we're still in the egg, just a few more weeks and we'll be out and loud.

[Schmeky]

KIM and OxSquidy,

I am of the opinion you guys are the closest thing to bring about potential recovery for chronics. I have not read of anything with this much recovery. Vaquero has published twice targeting chronics; no one else has accomplished this I'm aware of.

Keep the forum posted on the progress.

[jhorn4012]

KIM and OxSquidy,

I am of the opinion you guys are the closest thing to bring about potential recovery for chronics. I have not read of anything with this much recovery. Vaquero has published twice targeting chronics; no one else has accomplished this I'm aware of.

Keep the forum posted on the progress.

Schmeky,

This headline was in my Google Reader for 7/16/10. TCA Cellular Therapy, Covington, LA has been approved by FDA for Phase I clinical trial for complete SCIs using a person's own bone marrow. I had contacted the facility sometime in 2008-2009. Here's more info http://www.clinicaltrials.gov/ct2/show/NCT01162915?term=stem+cells+covington&rcv_d=14 and their website: http://www.tcacellulartherapy.com/fda_clinical_trials.html.
I know Dr. Young said, certain types of stem cell wouldn't heal CNS, but if everything works out for the completes and it shows some type of recovery we're going there for our daughter who is an incomplete c5 c6 injured 2007 once they start clinical trial for incompletes. I would be happy for her to have complete control of bowel and bladder and work on the walking situation later, which she is currently doing at Roll 2 Walk, Austin.

[Schmeky]

Jhorn4012,

I did not know this. However, the spinal cord Phase I is currently on hold (per the website). Inclusion criteria seems to be sub-acute.

I may contact this center for some additional info. This is only about 3 hours from my home. May even pay a visit and see what's going on, followed by a report. Gotta get my butt healed up first though.

[jhorn4012]

Jhorn4012,

I did not know this. However, the spinal cord Phase I is currently on hold (per the website). Inclusion criteria seems to be sub-acute.

I may contact this center for some additional info. This is only about 3 hours from my home. May even pay a visit and see what's going on, followed by a report. Gotta get my butt healed up first though.

I also noticed this after visiting the .gov site that their site is saying on hold. I couldn't verify from website how old that url link was.

Please take care of your health and let me know if you find out any info on TCA. I'm going to scan my Google Reader to see if anything else has come up. My daughter watches WDSU, New Orleans news about the Gulf Oil Spill and you would think something like a clinical trial not far from New Orleans would have this headliner on their local news cast. Maybe I should put in a word to the local WDSU station. We lived in New Orleans for 10 years and had to move after Katrina hit b/c of job situation. My husband has already said he would have no problems moving to Covington if our daughter was to get into a clinical trial.

[Leif]

Great news. Wonder also what the hold might be related to, and good luck for finding out David.

[luigi91377]

Dr. Wise,

What's your opinion on this type of procedure?

Thanx.

http://www.clinicaltrials.gov/ct2/show/study/NCT01162915?term=stem+cells+covington&rcv_s=07%2F06%2F2010&rcv_d=14

[Wise Young]

Dr. Wise,

What's your opinion on this type of procedure?

Thanx.

http://www.clinicaltrials.gov/ct2/show/study/NCT01162915?term=stem+cells+covington&rcv_s=07%2F06%2F2010&rcv_d=14

Dr. Alok Sharma in Bombay has already done some 220 patients, injecting bone marrow stromal stem cells intrathecally. I am not a fan of this procedure because I think that most of the cells end up in the cauda equina. Wise.

[GL]

I would love to try anything and because I believe in a simple word Called
( Hope )
Gypsylady

[steve nguyen]

Am I correct to think the clinical trails for ChinaSciNet will get results before SciNetUSA since you start the trails there first. Also, with all the red-tapes in USA from the FDA, the treatments will probably be available in China first. So, my question is, if the treatments are available in China, can we get it? I meant, would the US government allowed us to go to China to get treatments? Dont know about the costs yet but I want to get out of this wheelchair. It would be good to have it in USA, and get help from the insurances company to pay for part of the costs, but if the wait is too long, I would rather pay for the costs. I like to live the rest of my life being normal again, painfree, walking, and full B,B &S functions. Thank you Dr Young for all your hard works.

[Mike Bussolari]

rollon2011.com

[Wise Young]

Am I correct to think the clinical trails for ChinaSciNet will get results before SciNetUSA since you start the trails there first. Also, with all the red-tapes in USA from the FDA, the treatments will probably be available in China first. So, my question is, if the treatments are available in China, can we get it? I meant, would the US government allowed us to go to China to get treatments? Dont know about the costs yet but I want to get out of this wheelchair. It would be good to have it in USA, and get help from the insurances company to pay for part of the costs, but if the wait is too long, I would rather pay for the costs. I like to live the rest of my life being normal again, painfree, walking, and full B,B &S functions. Thank you Dr Young for all your hard works.

Steve, the results will be phase 1 and 2. To show efficacy for regulatory approval, one must complete two phase 3 trials, which we are planning to do in parallel in 2011. It will take at least a year (depending on our success in recruiting patients) to get the results. Wise.

[Mike Bussolari]

rollon2011.com (http://sci.rutgers.edu/forum/rollon2011.com)

[Mike Bussolari]

http://rollon2011.com
(http://rollon2011.com)

this one works

[Wise Young]

http://rollon2011.com
(http://rollon2011.com)

this one works

Mike,

I like your quote:
I'm not depressed because I'm in a wheelchair. I'm mad because the world is... and the chair ain't helpin'.


The quote contains two interesting ambiguities concerning why you are mad. Are you mad because the world is (or is not) depressed or because the world is in a wheelchair? For a moment, I had visions of the world, a green and blue globe, resting on a rubber cushion in an old wheelchair. Obviously, you must be mad that the world is (or is not) depressed by the sight of you in a wheelchair. Your side-comment that the chair is not helping would not make sense if the world is in a wheelchair. At first, I thought you are mad that the world is depressed by the sight of you in a wheelchair. Then, it occurred to me that it doesn't matter whether the world is or is not depressed. The maddening fact is that the world is not doing anything about it either way.

A while back, I gave a talk at the American Enterprise Institute where I said that it is all right to just take care of the victims of a disaster if you don't know that the disaster is coming and can do nothing to prevent the disaster. However, if you know that the disaster is coming and you could have stopped it but did not, then you are responsible for the disaster. The same thing could be said about injuries that result from war. When our nation sends soldiers to war, we know that thousands will come back with devastating brain and spinal cord injuries. Scientists believe that there will be treatments that will restore function to such people. If we send soldiers to war and don't even try to do something about it, then we are doubly responsible for the tragedy.

Christopher Reeve once said along the same vein. He said (I am paraphrasing) that he would not be so upset if scientists said to him that the task of curing spinal cord injury is incredibly difficult and will take a long time. What is unacceptable to him is that scientists are saying that spinal cord injury can be cured but it is taking a long time because of politics and lack of funding. That was what irked him so much about the stem cell wars, that politicians would quibble about cells that were being thrown away while people were trapped in the wheelchairs or dying of their diseases.

Wise.

[Imight]

Steve, the results will be phase 1 and 2. To show efficacy for regulatory approval, one must complete two phase 3 trials, which we are planning to do in parallel in 2011. It will take at least a year (depending on our success in recruiting patients) to get the results. Wise.

I haven't been on here in a bit as regularly as I used to be.

Has chinascinet begun injecting stem cells?

How's it going? (you probably can't answer that, but a vague 'looks promising or not' works enough for me lol)

[Leif]

... The quote contains two interesting ambiguities concerning why you are mad. Are you mad because the world is (or is not) depressed or because the world is in a wheelchair? For a moment, I had visions of the world, a green and blue globe, resting on a rubber cushion in an old wheelchair. Obviously, you must be mad that the world is (or is not) depressed by the sight of you in a wheelchair. Your side-comment that the chair is not helping would not make sense if the world is in a wheelchair. At first, I thought you are mad that the world is depressed by the sight of you in a wheelchair. Then, it occurred to me that it doesn't matter whether the world is or is not depressed. The maddening fact is that the world is not doing anything about it either way.
The thing is that most are more interested in the wheelchair than the cure.

[Wise Young]

I haven't been on here in a bit as regularly as I used to be.

Has chinascinet begun injecting stem cells?

How's it going? (you probably can't answer that, but a vague 'looks promising or not' works enough for me lol)

Imight, I answered your question in another post. We are still recruiting. The original trial design was that we would start transplanting as soon as we recruit 20 patients and randomize them to the five planned treatment groups. We can start randomizing as soon as we get five subjects and then randomize again when we get another five subjects. In addition, we are applying for permission to use sequential allocation rather than randomization. We will be transplanting our first subjects soon.

Wise.

[mckeownp]

yes !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! !!!!!!!!

[lepups3]

You just made my year Dr. Young.

[Mike Bussolari]

Wise, I appreciate the analysis, and you're right. I'm mad (angry) because the world is disabled, and I'm also mad because the world is mad (crazy).

To have knowledge of such advancements as stem cells, solar panels, electric energy etc. but not utilize them as much as possible is insane.

I can't imagine what it is about our overmedicated oversexed overly religious paranoid on-demand text messaging fast food ADD culture, but apathy has officially reached its golden age.

And I have bad days where I don't care we're killing ourselves, and I think we deserve it for being so arrogant and treating the earth with such entitlement as we do, but those days are one in 100.

On the other 99 days, I firmly believe that most of my fellow human beings are filled with hope and optimism, but it's just too damn painful to be honest with yourself and see the world for what it is, and examine your own life. I was this way for the first few years in a chair. I kept my head down and did what I had to do to stay healthy, having an almost naïve certainty that medical science would find me very soon and I would be ready. Until then, I'll just block everything else out.

But when I finally looked up after four years and took a look around, I realized that almost nothing had changed, and we're all to blame. People have good reason to put their hope in you and your trial, I myself have, but what will we do if the results aren't what we hoped they would be, a year or two from now? We'll all just sigh and feel terrible and continue to wait and do nothing personally to take responsibility.

I don't know if this is the answer, but it's the best one I have.
http://rollon2011.com

By the way, you must have gotten this before, but you changed your name to Wise after you became a scientist right? Be honest.

[Mike Bussolari]

Also, do you have any ideas, legislative or otherwise that might help our cause?

[Mike Bussolari]

After a message from Steven Edwards, I'm thinking about shifting gears away from the rally in DC and putting all my efforts behind this for now...
http://bodyshockthefuture.org/ideas.php?st=veterans&reset_pe=1

[sunchine]

probably this has or has nothing to do with this or probably is not the right place to ask but my question is are we in this forum going to be elegible to voluntier for the steem cell trials or not.

[Jim]

sunchine,

It will be up to the investigators at each hospital to choose participants for the clinical trials. Everyone who fits the inclusion criteria will be eligible.-

http://www.scinetusa.org/
The proposed Phase 3 trial protocol will focus on subjects with ASIA A (complete) traumatic injuries who are chronic, that is, injured over one year, with six months of stable neurological function. Addition criteria include vertebral levels C5 through T10 and ages 18-65. Separate Phase 2 trials are planned for children 8-17 and adults 65-80. At the beginning of the Observational Phase, participants will be evaluated and then followed for six months. During this time they will be encouraged to stand in a standing frame, standing wheelchair, or similar device for increasing lengths of time until they are able to stand and be weight-bearing in such a device for at least one hour a day.

[e.t.]

Dr. Tabakov. if we have something new? whether it is something new in the latest patient?

[jhorn4012]

sunchine,

It will be up to the investigators at each hospital to choose participants for the clinical trials. Everyone who fits the inclusion criteria will be eligible.-

http://www.scinetusa.org/
The proposed Phase 3 trial protocol will focus on subjects with ASIA A (complete) traumatic injuries who are chronic, that is, injured over one year, with six months of stable neurological function. Addition criteria include vertebral levels C5 through T10 and ages 18-65. Separate Phase 2 trials are planned for children 8-17 and adults 65-80. At the beginning of the Observational Phase, participants will be evaluated and then followed for six months. During this time they will be encouraged to stand in a standing frame, standing wheelchair, or similar device for increasing lengths of time until they are able to stand and be weight-bearing in such a device for at least one hour a day.

Jim,

A forum blog from apparalyzed sent me this link to youtube video http://www.youtube.com/watch?v=mtPwGZ4y428. All I could find was the following links: the company is called InVivo Therapeutics and they are waiting for FDA approval on a new clinical trial recently being submitted according to the video link. Here are the links I could find http://www.invivotherapeutics.com/about.php . I couldn't find anything on National Geographic website airing the special on this procedure. So, I'm not sure how creditable this info from video is.

Here's a little quote about the device and how it works for SCI and in the video they show a monkey as test subject: We have designed an implant modeled after the intact spinal cord consisting of a multi-component polymer scaffold. Implantation of the scaffold into an adult rat model of SCI promoted long-term improvement in function relative to a lesion-control group. At 70 days post injury, animals implanted with scaffold-plus-cells exhibited coordinated, weight-bearing hind limb stepping. Histology and immunocytochemical analysis suggested that this recovery might be attributable partly to a reduction in tissue loss from secondary injury processes as well as in diminished glial scarring. Tract tracing demonstrated corticospinal tract fibers passing through the injury epicenter to the caudal cord, a phenomenon not present in untreated groups. Together with evidence of enhanced local GAP-43 expression not seen in controls, these findings suggest a possible regeneration component. These results may suggest a new approach to penetrating SCI and, more broadly, may serve as a prototype for multidisciplinary strategies against complex neurological problems, including contusion SCI.

[jhorn4012]

Please see post I made on 9/6/10 at noon to Jim Bennett.

[pulaski]

Dr. Tabakov. if we have something new? whether it is something new in the latest patient?

--------------------------
I have some info. from not offical source about new collaboration with the polish team. I think Dr. Tabakov will inform us soon abaut this.

[Mac85]

--------------------------
I have some info. from not offical source about new collaboration with the polish team. I think Dr. Tabakov will inform us soon abaut this.
co sie dzieje

[Mr. Willie]

Since I have been doing research on clinical trials in the U.S I have recodnized that most companies conducting the trials require that candidates be ASIA A (complete level) for both acute and chronic injuries. What about ASIA B level candidates with incomplete injuries?

[0xSquidy]

Since I have been doing research on clinical trials in the U.S I have recodnized that most companies conducting the trials require that candidates be ASIA A (complete level) for both acute and chronic injuries. What about ASIA B level candidates with incomplete injuries?

To my knowledge, incomplete injuries can improve a lot only by physical therapy. That means that if you take an ASIA B into a clinical trial and then the corresponding physiotherapy, if there are improvements, how can you tell they come from the trial treatment itself or the exercise?

ASIA A are good for one thing, if you get better with something, that something works. Once it's proved the treatment works, it can most certainly improve other ASIA scales.

edit: i just thought about the control group...sigh

[Buck503]

Since I have been doing research on clinical trials in the U.S I have recodnized that most companies conducting the trials require that candidates be ASIA A (complete level) for both acute and chronic injuries. What about ASIA B level candidates with incomplete injuries?

Wise has said that the goal is to make completes incomplete
and incompletes more incomplete. He's also posted some
statistics that suggest incompletes often make good recoveries
through rigorous physical therapy.

[keeping on]

Does anybody know when Geron is starting their trials for acutes? Does anybody know when Emory Medical is starting their trials for spinal injuries? We know that Wise is starting his trials on Oct 15th of this year.

[keeping on]

http://neuro.cjb.net/cgi/content/full/25/19/4694 note in the first part of release; early treatment of spinal injury (7days); remylination can occur. Later treatment of injury says no remyelination. What research shows us chronics that remyelination can occur?

[pulaski]

co sie dzieje

Here we are. info. from the Medical Academy in Wroclaw Poland newsletter.

W dniach 17.06.–20.06.2010 r.
Klinikę Neurochirurgii wrocławskiej
Akademii Medycznej odwiedzili
prof. Geoff rey Raisman oraz
jego współpracownicy – Daging Li,
Ying Li i David Warner ze Spinal
Repair Unit of the Institute of Neurology
University College London.
Uczestniczyli jako obserwatorzy
w nowatorskiej operacji transplantacji
autogenicznych glejowych
komórek węchowych do rdzenia
kręgowego pacjenta z jego całkowitym
urazowym uszkodzeniem.


Podsumowując swoją
wizytę we Wrocławiu, w liście do
dr. Pawła Tabakowa z Kliniki Neurochirurgii
prof. Raisman napisał:
I am really grateful to you, your
colleagues and your chairman for the
very kind and lavish hospitality, and
for letting me share in the excitement
of the transplantation. Most important
I think this visit gave us a chance
to get to understand each other as
people. In my experience it is rare to
fi nd such a close connection and personal
chemistry, and I greatly value
it. It comes at a very important time
for our fi eld. I think your clinical protocol
is the most perfect, and I think
it will be the way forward for OEC
transplantation.

[Mac85]

Here we are. info. from the Medical Academy in Wroclaw Poland newsletter.

W dniach 17.06.–20.06.2010 r.
Klinikę Neurochirurgii wrocławskiej
Akademii Medycznej odwiedzili
prof. Geoff rey Raisman oraz
jego współpracownicy – Daging Li,
Ying Li i David Warner ze Spinal
Repair Unit of the Institute of Neurology
University College London.
Uczestniczyli jako obserwatorzy
w nowatorskiej operacji transplantacji
autogenicznych glejowych
komórek węchowych do rdzenia
kręgowego pacjenta z jego całkowitym
urazowym uszkodzeniem.


Podsumowując swoją
wizytę we Wrocławiu, w liście do
dr. Pawła Tabakowa z Kliniki Neurochirurgii
prof. Raisman napisał:
I am really grateful to you, your
colleagues and your chairman for the
very kind and lavish hospitality, and
for letting me share in the excitement
of the transplantation. Most important
I think this visit gave us a chance
to get to understand each other as
people. In my experience it is rare to
fi nd such a close connection and personal
chemistry, and I greatly value
it. It comes at a very important time
for our fi eld. I think your clinical protocol
is the most perfect, and I think
it will be the way forward for OEC
transplantation.
duzo nie powiedzial...:sorry!:

[keeping on]

Wise, this aritcile http://www.ajc.com/health/ga-in-stem-cell-684287.html, it says that Geron's trial for acute's within 14 days of injury are because the thery will occurr before the sinal scar is formed. I'm confudes to whaqt it means and remember you saying that scarring doesn't occurr. Can you lease explain why the test is viewed onlyu for acutes within 14 days of damage?

keeping on

[Wise Young]

Wise, this aritcile http://www.ajc.com/health/ga-in-stem-cell-684287.html, it says that Geron's trial for acute's within 14 days of injury are because the thery will occurr before the sinal scar is formed. I'm confudes to whaqt it means and remember you saying that scarring doesn't occurr. Can you lease explain why the test is viewed onlyu for acutes within 14 days of damage?

keeping on

Keeping on,

Hans Keirstead found that the cells were not beneficial when applied to injured spinal cords more than two weeks after the injury. In my opinion, the suggestion that this timing is because "scar" has formed is at best highly speculative. There are many reasons why the cells may not be effective when transplanted more than 2 weeks after injury.

1. They are transplanting oligodendroglial progenitor cells that myelinate axons. One possibility is that the cells are not myelinating efficiently after 2 weeks.

2. Chondroitin-6-sulfate-proteoglycans (CSPG) also accumulate around the injury edge and CSPG is known to stop migration of the cells that are transplanted into the middle of the injury site. You can get around that by transplanted the cells at the edges of the injury site and the cells will migrate into the injury site and form a bridge across the injury site and edges. I believe that Keirstead's study transplanted the cells into the injury site.

3. The injury site expresses cytokines and neurotrophins. Neurotrophin levels decline after 2 weeks. It is possible that the extracellular environment of the injury site is not as conducive to stimulating the oligodendroglial progenitor cells (OPC's) to produce growth factors.

In the Geron trial, according to the Ed Wirth who presented about the trial to our Open House this summer, the OPC's will be transplanted into the cord surrounding the injury site. A lot of people asked Ed Wirth whether or not Geron is planning to apply the cells in chronic spinal cord injury. He correctly replied that he does not know until they show that the cells are safe when transplanted into the spinal cord. One step at a time.

Wise.

[keeping on]

Wise, thank you. The answer is above my grade level, but I will try to understand. It appears that at this time the therapy doesn't apply to chronics. We will all be waiting with baited breath on the results of the trials in China and hopefully later in the states with your treatment. I pray for all, the researchers and th epatients, and even those who hailagainst the stem cell treatments using embryonic cells. It's going to happen .

keeping on

[Chris Chappell]

I hope your prayers are answered keeping on.

[NowhereMan]

Keeping on,

Hans Keirstead found that the cells were not beneficial when applied to injured spinal cords more than two weeks after the injury. In my opinion, the suggestion that this timing is because "scar" has formed is at best highly speculative. There are many reasons why the cells may not be effective when transplanted more than 2 weeks after injury.

1. They are transplanting oligodendroglial progenitor cells that myelinate axons. One possibility is that the cells are not myelinating efficiently after 2 weeks.

2. Chondroitin-6-sulfate-proteoglycans (CSPG) also accumulate around the injury edge and CSPG is known to stop migration of the cells that are transplanted into the middle of the injury site. You can get around that by transplanted the cells at the edges of the injury site and the cells will migrate into the injury site and form a bridge across the injury site and edges. I believe that Keirstead's study transplanted the cells into the injury site.

3. The injury site expresses cytokines and neurotrophins. Neurotrophin levels decline after 2 weeks. It is possible that the extracellular environment of the injury site is not as conducive to stimulating the oligodendroglial progenitor cells (OPC's) to produce growth factors.

In the Geron trial, according to the Ed Wirth who presented about the trial to our Open House this summer, the OPC's will be transplanted into the cord surrounding the injury site. A lot of people asked Ed Wirth whether or not Geron is planning to apply the cells in chronic spinal cord injury. He correctly replied that he does not know until they show that the cells are safe when transplanted into the spinal cord. One step at a time.

Wise.


Hi Dr. Wise,

I thought the reason why the remyelination therapy wont work is because there is nothing to remyelinate at the injury site of a chronic complete sci. I saw an MRI of my spinal cord a year post injury and there was no cord between c6-8 (my injury level) all there was was celebral spinal fluid. And it wasn't severed with bone or a knife, just contused. But for all intents and purposes my cord was severed. That is why i am a complete injured. So my question is why would anyone expect a remyelination therapy to work in a chronic complete injury if theres no cord to remyelinate? Obviously, i know little on the science of it all that is why i am asking. Thanks

[rexio]

http://i54.tinypic.com/96j4h4.jpg


Professor Raisman and his team with Dr.Tabakov and his team after their conference in Wroclaw, Poland.

source: Medical Academy newsletter

[keeping on]

Wise, have the trials started in China or are they to start this upcoming week? Anyway, good luck to you and your team, the patients being tested, and to the future of us all.

keeping on

[Wise Young]

Hi Dr. Wise,

I thought the reason why the remyelination therapy wont work is because there is nothing to remyelinate at the injury site of a chronic complete sci. I saw an MRI of my spinal cord a year post injury and there was no cord between c6-8 (my injury level) all there was was celebral spinal fluid. And it wasn't severed with bone or a knife, just contused. But for all intents and purposes my cord was severed. That is why i am a complete injured. So my question is why would anyone expect a remyelination therapy to work in a chronic complete injury if theres no cord to remyelinate? Obviously, i know little on the science of it all that is why i am asking. Thanks

NowhereMan,

I have spoken to Ed Wirth of Geron about this issue. He said to me that there is evidence that the oligodendroglial progenitor cells are producing growth and other factors that improve repair after spinal cord injury. It may be one of the reasons why the treatment is only effective when given within 2 weeks after injury.

The phase 1 trial also is not designed nor powered to provide efficacy data. It is designed to show feasibility and safety. Please also note that the FDA requires Geron to wait a month between every case to show that the treatment is safe, before proceeding to the next case. So, we should soon be hearing about a second case, since the first case occurred more than a month ago.

Wise.

[lepups3]

Dr Wise;

In your opinion, would the presence of a shunt or cord untethering surgery affect the way the spine would react to any time of stem cell treatent?

Thank you

[Wise Young]

Dr Wise;

In your opinion, would the presence of a shunt or cord untethering surgery affect the way the spine would react to any time of stem cell treatent?

Thank you

Lepups,

Having had a previous surgery with exposure of the spinal cord may affect your candidacy for a clinical trial that involves exposing the spinal cord. Surgeons are sometimes reluctant to re-open through an existing laminectomy scar, which usually tends to be highly vascular (therefore hemorrhagic) and may be adherent to the dura and surrounding tissues (increasing the risk of tearing the dura and other structures). We are hoping to avoid that situation by exposing the spinal cord above and below the injury site. As surgeons get more experience with such surgeries, however, I think that they would be more willing to do them.

In terms of how a shunt may affect stem cells, I think that the main issue is the presence of a syringomyelic cyst. A cyst obviously reduces the amount of tissue that axons can regenerate through. In our ChinaSCINet trial, we are considering using the criteria that syringomyelic cysts should not be over 50% of the diameter of the spinal. By the way, we do not know and did not incorporate this into the formal inclusion and exclusion criteria but left the decision to the discretion of the surgeon.

We do not automatically exclude subjects who have syrinxes or shunts. Obviously, we will not know whether treatments restore function in such subjects until we try.

Wise.

[DannyCox707]

Dear Dr. Young,

Our son (Danny) is a complete C6 as of 8/10/2010. It seems that there are no clinical trials planned for this level of injury (we understand why). He is deteriorating and losing hope. We feel like we have to do something soon to get him going again. We are leery of the stem cell tourism clinics and all roads seem to be pointing toward Dr. Lima in Portugal.

Danny was an athlete in peak physical condition at the time of his injury, but is now losing his strength. We have the resources to go to Portugal, but cannot find adequate information. Are we jumping the gun? It seems like even if the trials are successful, treatment will still be years away.

Thank you for all of your hard work and keeping everyone informed.

[0xSquidy]

Dear Dr. Young,

Our son (Danny) is a complete C6 as of 8/10/2010. It seems that there are no clinical trials planned for this level of injury (we understand why). He is deteriorating and losing hope. We feel like we have to do something soon to get him going again. We are leery of the stem cell tourism clinics and all roads seem to be pointing toward Dr. Lima in Portugal.

Danny was an athlete in peak physical condition at the time of his injury, but is now losing his strength. We have the resources to go to Portugal, but cannot find adequate information. Are we jumping the gun? It seems like even if the trials are successful, treatment will still be years away.

Thank you for all of your hard work and keeping everyone informed.

Don't do it. That will only take your money and hopes away. Can be harmful too.

Desperate acts haven't helped anyone I know, specially with Dr. Lima...

[kate]

Dear Dr. Young,

Our son (Danny) is a complete C6 as of 8/10/2010. It seems that there are no clinical trials planned for this level of injury (we understand why). He is deteriorating and losing hope. We feel like we have to do something soon to get him going again. We are leery of the stem cell tourism clinics and all roads seem to be pointing toward Dr. Lima in Portugal.

Danny was an athlete in peak physical condition at the time of his injury, but is now losing his strength. We have the resources to go to Portugal, but cannot find adequate information. Are we jumping the gun? It seems like even if the trials are successful, treatment will still be years away.


I'm so sorry to hear that your son is losing hope; this is actually a time of great hope -- but also a time to be careful.

This document (http://icord.org/wp-content/uploads/2009/07/Experimental_treatment_for_SCI-summary.pdf) has a clear & concise discussion of what to look for in clinical trials . . . I especially recommend the last page, where the authors (who are legitimate and knowledgeable) lay out the questions every person considering any sort of treatment needs to ask, along with what to listen for in the answers.

The first months post injury are a nightmare, but they don't last forever.

[jhorn4012]

Dear Dr. Young,

Our son (Danny) is a complete C6 as of 8/10/2010. It seems that there are no clinical trials planned for this level of injury (we understand why). He is deteriorating and losing hope. We feel like we have to do something soon to get him going again. We are leery of the stem cell tourism clinics and all roads seem to be pointing toward Dr. Lima in Portugal.

Danny was an athlete in peak physical condition at the time of his injury, but is now losing his strength. We have the resources to go to Portugal, but cannot find adequate information. Are we jumping the gun? It seems like even if the trials are successful, treatment will still be years away.

Thank you for all of your hard work and keeping everyone informed.


Sorry to hear about Danny's accident. You found the right forum to get the best info on all things to do with spinal cord injuries. You are listing your location in California, please checkout Project Walk in the San Diego area. This program is doing some amazing things to help people with spinal cord injury. Their website url is www.projectwalk.org. Also please check out my daughter's progress at a facility that is following the same methods of physical therapy at Roll 2 Walk in Austin, Tx. Her blogsite: http://thesam4r2wblog.blogspot.com All I can say it's worth every dollar we have spent to keep our daughter physically fit and healthy. There is no other program like Roll 2 Walk that she can go to that our insurance will pay. She is only getting a 1 hr. physical therapy once a week through our insurance plan and you'll find out in this forum it is necessary to do at least 3 hrs. of physical therapy 3 times to 5 times a week. Welcome to the forum.

[keeping on]

A qiestion for Wise. I've followed articles by different organizaiotns on upcoming trials for therapy. Some mention things in the future and others plainly say they don't know of any. None have mentioned yours. Seems to be a disconnect on information on current events. Do you have idea what's up and are your trials starting today in China?

keeping on

[wilfried]

I haven't visited the cc-forum for a while and somebody may have posted this already.

I read in a journal that the FDA did not allow Novartis to start the ATI355 trial in the US earlier because they had concerns about the continous release of the antibody directly into the spinal cord.

Now - obviously since there were no side-effects after 3 years - and Novartis applies a mix of direct release and injections of the antibody into the spinal cord, the FDA approved the trial in the US:
http://clinicaltrials.gov/ct2/show/NCT00406016?term=ATI355&rank=1
http://www.methodisthealth.com/tmhs/centersOfExcellence.do?channelId=-1073829559


Yes, DannyCox they are recruiting for the Novartis anti-Nogo trial, although only 28 days post injury, but your son would have been a candidate, because they include complete injuries below C5.

[keeping on]

Try this; Dear Tony,

Unfortunately Ella has now left for the Christmas break so thought I would respond on her behalf. We are indeed aware of the Myelin Repair Foundation, as well as many other funders in this area and as best we can we look to collaborate with them in order to speed up the process of new discovery and translation into clinical trials. In fact, researchers collaborate very widely too and our researcher at Cambridge, for example, collaborate with other leading myelin repayir researchers in the UK, Europe and around the rest of the world. So, I can assure you that the very best efforts are going into developing new therapies for MS.

However, although it is necessary to go through the research and clinical trial process, I agree that it is incredibly frustrating how long these things take. I hope that you are reassured that your MS Society is doing all it can in its power to speed this process up by funding the right research, the right researchers and by promoting collaboration as much as possible (from a funding and research angle).

With very best wishes
Doug
Head of Biomedical Research

[Leif]

Try this; Dear Tony,

Unfortunately Ella has now left for the Christmas break so thought I would respond on her behalf. We are indeed aware of the Myelin Repair Foundation, as well as many other funders in this area and as best we can we look to collaborate with them in order to speed up the process of new discovery and translation into clinical trials. In fact, researchers collaborate very widely too and our researcher at Cambridge, for example, collaborate with other leading myelin repayir researchers in the UK, Europe and around the rest of the world. So, I can assure you that the very best efforts are going into developing new therapies for MS.

However, although it is necessary to go through the research and clinical trial process, I agree that it is incredibly frustrating how long these things take. I hope that you are reassured that your MS Society is doing all it can in its power to speed this process up by funding the right research, the right researchers and by promoting collaboration as much as possible (from a funding and research angle).

With very best wishes
Doug
Head of Biomedical Research
Keeping on - have you spiralled into the dark madness like the rest.

[keeping on]

leif; nope.

keeping on

[Wise Young]

I received the following email and here is my response:

> The following message was sent to you via the CareCure Forums Contact Us form by tahn@carecure
>
> --------------------------------
>
> what r the cures u hav for SCI?
> i am an Incomplete with a break @ T-3 and T-4
> wondering wats out there for help or cure?
>
> --------------------------------
>

tahn,

There is no cure yet. Several therapies are now undergoing formal clinical trials:
Oligodendroglial progenitor cells derived from human embryonic stem cells for subacute (within 2 weeks) injury: Geron (http://clinicaltrials.gov/ct2/show/NCT01217008?)
HLA-matched umbilical cord blood cells and lithium for chronic (>1 years): ChinaSCINet (http://clinicaltrials.gov/ct2/show/NCT01046786?)
Nogo antibody for subacute spinal cord injury (4-14 days): Novartis (http://clinicaltrials.gov/ct2/show/NCT00406016?).
Intrathecally administered autologous bone marrow mesenchymal stem cells: TCA Cellular Therapy (http://clinicaltrials.gov/ct2/show/NCT01162915?)
Intraspinal transplantation of autologous nasal mucosa: Wroclaw Medical University (http://clinicaltrials.gov/ct2/show/NCT01231893?)


Several clinics are charging people for unsubstantiated cell transplant therapies. These include:
Intraspional fetal olfactory ensheathing glia (OEG) transplants (Hongyun Huang in Xishan Hospital, Beijing, China)
Autologous nasal mucosa (Carlos Lima)
intrathecal and intramuscle injections of so-called embryonic stem cells (Geeta Shroff in New Delhi, India)
intrathecal administration of bone marrow cells (X-cells in Cologne, Germany)
intrathecal and intravenous administration of non-matched umbilical cord blood cells (Beike Biotech, Shenzhen, China)


Many other places in the Carribean, Mexico, Panama, India, and China that are offering cell therapies for pay. In my opinion, people should not be paying for unsubstantiated therapies. I am hopeful that one or more of the clinical trials will show positive results.

Wise.

[steve nguyen]

Thank You Dr Young. Happy New Year to all.

[keeping on]

Guys, we are , of course, concentratin gon clinical trials for spinal cord. However, their are a number of approvals by the FDA, for other ailments. they are coming fast and furious. Recently, several trials for blindness, chemical burns and macular degeneration, have been approved and in testing phase. chemical blindness was treated withs tem cells in italy and was a flying success. We won't be far behind. let's hope we can concentrate solely on all trials including ours for 2011.

keeping on

[jhorn4012]

Guys, we are , of course, concentratin gon clinical trials for spinal cord. However, their are a number of approvals by the FDA, for other ailments. they are coming fast and furious. Recently, several trials for blindness, chemical burns and macular degeneration, have been approved and in testing phase. chemical blindness was treated withs tem cells in italy and was a flying success. We won't be far behind. let's hope we can concentrate solely on all trials including ours for 2011.

keeping on

Let us hope SCI will be nextin line for clinical trials for chronic.

[keeping on]

jhorn, I hope so too. With all the stem cell treatments currently going on and the trials for spinal cord occurring; I feel 2011 is going to be a big year.

keeping on

[poobear]

keeping on as a computer no nothing i am lost on how to get back to the place wher we were talking. PLEASE GIVE ME LAYMANS DIRECTIONS TO GET BACK THANKS POOBEAR

[poobear]

Keeping on in order to attempt to help we were talking about your use of amprya and my having a 30 day supply.

[keeping on]

poobear, I gave you a comprehensive answer of my experience. Your 30 day supply is between and your doctor and the company. If you have ms, it may help you, if not try it and see.

keeping on

[poobear]

keeping on where are you ??? poobear

[poobear]

no i don't have ms i have sci i was NOT trying to peek your hole card keeping on i was just trying to see how far i should go with it based on your imput ment no disrespect best of luck to you poobear

[keeping on]

http://www.bizjournals.com/triangle/news/2011/01/05/aldagen-wins-fda-ok-to-test-stroke-treat.html; here's another clinical trial approval, this one for stroke. They're coming fast and futious.

keeping on

[poobear]

Just read about chitosan today anyone know any thing about it?? Article in science daily [4-18-2010] and posted on care cure by kalme001 says that it could repar spinal cord damage. Most exciting article i have read since comming down with sci. Poobear

[keeping on]

http://sci.rutgers.edu/forum/mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://gallery.mailchimp.com/513b92eb0bf6c17f06cca149d/images/Stemcellnewsletter.jpg (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=d1ba6a701d&e=3c3210452e) Message from Bernard Siegel, Executive Director, Genetics Policy Institute (GPI) and Founder of the Stem Cell Action Campaign
Lame duck session ends lamely for stem cell research

The just concluded lame duck session of Congress did not bode well for the 73% of the US population that supports the advancement of human embryonic stem cell research. Despite concentrated effort of research proponents including more than 2,000 letters to Congress launched from the Stem Cell Action web site (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage1.com/track/click?u=513b92eb0bf6c17f06cca149d&id=fe3e3d91b8&e=3c3210452e), the Stem Cell Research Advancement Act did not budge even an inch towards passage.

The newly elected 112th Congress has fewer friends of scientific research, and some of the newly empowered seem poised to take their hatchets to the NIH research budget. To make matters worse, many observers expect the emboldened anti-science crowd to unleash a number of draconian proposals to halt the study of human embryonic stem cells and roll back funding, even eliminating funding for the Bush stem cell lines. (In the anti-science push, this roll back could extend to non-human embryonic stem cells, as well as tissue specific cells (also referred to as adult stem cells.)

All is not lost, however, we have identified champions of patients on both sides of the aisle. We must redouble our efforts to reach out to our lawmakers to protect this potentially lifesaving and lifegiving field.



New clinical trial underscores ridiculous opposition talking point
It was announced at the beginning of this first week of 2011 that Advanced Cell Technology will be allowed to launch its second clinical trial (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage2.com/track/click?u=513b92eb0bf6c17f06cca149d&id=36abd5f237&e=3c3210452e) utilizing human embryonic stem cells targeting macular degeneration, an eye disease impacting 25-30 million people worldwide.

This trial helps spotlight one of the most ridiculous talking points ever devised by stem cell research foes: the tired bromide that embryonic stem cells have produced no treatments, with the implication that the field is somehow “junk science.” It is mind boggling how this argument is mindlessly repeated by opponents over and over. The scientific method we all learned in middle school taught us you can’t see scientific results until you do the experiment! The fact is that funding for hESCR has been most limited in the United States for more than a decade, and in spite of this, we now have three new clinical trials that FDA has allowed to proceed.

hESCs were only first isolated and cultured in 1998, and by any reasonable yardstick the field has advanced and is continuing to advance rapidly. How much further would we be if the research foes had not derailed substantial funding for all those years? And how much more time will we lose because of the federal lawsuit Sherley v. Sebelius?

It is a hugely complex and expensive process to move from the laboratory into clinical trials. Research foes play to the absence of widespread public understanding of basic science and the Herculean task of translating that science into medicine. Those of us who favor the undertaking of this science and its translation into medicine must be prepared to set the record straight when we read or hear such vacuous comments.

Of course, it is critically important for researchers to inform the public about their work and do so in a way that can be easily understood. This topic is the subject of a brilliant essay in the 2010 World Stem Cell Report by Dr. M. William Lensch titled “Science Education as Science Advocacy: A Personal View.” That essay can be downloaded at no charge here (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=4d53b91a76&e=3c3210452e).


Embryonic stem cells will measure up
Dr. John McDonald, a wonderful humanitarian and director of the International Center for Spinal Cord Injury at the Kennedy Krieger Institute in Baltimore, a longtime stem cell researcher and one of Christopher Reeve’s physicians, said in an essay at CNN Health that human embryonic stem cells and embryonic stem cells in general "are one of the greatest scientific tools of the 21st century." To read all of Dr. McDonald’s views see his commentary here (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=01c1ca89a3&e=3c3210452e).


New Endorsers- Stem Cell Action Coalition Surges
The Stem Cell Action Campaign surged to 52 members adding eight new endorsing groups: the Central Illinois Advocates for Lives Interrupted by Parkinson’s Support Organization (CALIPSO) (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=70691093ad&e=3c3210452e) , A. Alfred Taubman Medical Research Institute (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=23f63e27f3&e=3c3210452e), I Believe Incorporated (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=f70ecedd8f&e=3c3210452e), Cell Transplant Society (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=a61eb97245&e=3c3210452e), American Council on Science and Health (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage1.com/track/click?u=513b92eb0bf6c17f06cca149d&id=4cf14c9e53&e=3c3210452e), UK Stem Cell Network (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=0a19724ef7&e=3c3210452e), London Regenerative Medicine Network (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=0d70eaaae2&e=3c3210452e) and the Multiple Sclerosis Activism Foundation (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=8911a49c32&e=3c3210452e).

Join the Stem Cell Action Campaign
The Stem Cell Action Coalition serves as an engine to unite the pro-cures community. It recognizes that human embryonic stem cell research must be a national public health priority at all branches and levels of government, both federal and state, not only as a matter of the medical health of the individuals who comprise the United States, but also as a matter of national financial health.

Already joined by 52 organizations, the Coalition sponsors a web site www.stemcellaction.org (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage1.com/track/click?u=513b92eb0bf6c17f06cca149d&id=0a9977a79f&e=3c3210452e) and is actively engaged in social media. We urge you to become a follower of the Coalition on Twitter (@StemCellAction). In addition, the Coalition publishes this online bi-monthly newsletter “Stem Cell Action News”. This newsletter is disseminated to a database of more than 40,000.

To forge a permanent and unparalleled community of conscience and commitment, the Stem Cell Action Coalition seeks to recruit hundreds of organizations nation-wide.

Together we can speak with one voice, so our elected officials in the legislative and executive branches of government can no longer ignore our clearly spoken will: to protect and advance human embryonic stem cell research.

Please take action today:

Visit www.stemcellaction.org (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage1.com/track/click?u=513b92eb0bf6c17f06cca149d&id=d6d5407c27&e=3c3210452e) and send a letter to your Congressional representatives to support stem cell research.
Follow us on Twitter @StemCellAction.
Demonstrate your organization’s support for stem cell research by endorsing the Stem Cell Action campaign. This simple gesture serves as an expression of solidarity with the organizations and thousands of families already supporting this promising field of biomedical research and clinical development, with a shared goal to alleviate human suffering. Please send us your organization’s authorization to post your logo on the campaign web site. Send the authorization (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:mailto:alan@genpol.org?subject=I%27d%20like%20 to%20endorse%20the%20Stem%20Cell%20Action%20campai gn).
Make an online donation (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=3af46db821&e=3c3210452e) to the Stem Cell Action campaign. Proceeds will be used to advance the campaign.



To reach the Stem Cell Action coalition, please call toll free at 888-238-1423 or email our director of public outreach, Alan Fernandez at alan@genpol.org (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:mailto:alan@genpol.org).

Editorialhttp://sci.rutgers.edu/forum/mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://gallery.mailchimp.com/513b92eb0bf6c17f06cca149d/images/actnow.jpg (mhtml:{9C0D1C96-002D-4021-BCAD-E3E554C0C177}mid://00000000/!x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=48b7fd7870&e=3c3210452e)
Bernard Siegel
Executive Director
Genetics Policy Institute hope this works; tells about the progress on stem cell research funding from the gov'tment.

keeping on

[keeping on]

Sound Familiar? http://www.stuff.co.nz/sunday-star-times/features/4542836/Lobbyists-anxiously-await-stem-cell-trial-decision; let's hope that around the world,l voices speak up and our mission is recognized.

[Scaper1]

Wow. With friends like that, who needs enemies?

[keeping on]

scaper, I don't know about friemds; but the reality is what it is.

keeping on

[chris arnold]

http://sci.rutgers.edu/forum/mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://gallery.mailchimp.com/513b92eb0bf6c17f06cca149d/images/Stemcellnewsletter.jpg (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=d1ba6a701d&e=3c3210452e) Message from Bernard Siegel, Executive Director, Genetics Policy Institute (GPI) and Founder of the Stem Cell Action Campaign
Lame duck session ends lamely for stem cell research

The just concluded lame duck session of Congress did not bode well for the 73% of the US population that supports the advancement of human embryonic stem cell research. Despite concentrated effort of research proponents including more than 2,000 letters to Congress launched from the Stem Cell Action web site (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage1.com/track/click?u=513b92eb0bf6c17f06cca149d&id=fe3e3d91b8&e=3c3210452e), the Stem Cell Research Advancement Act did not budge even an inch towards passage.

The newly elected 112th Congress has fewer friends of scientific research, and some of the newly empowered seem poised to take their hatchets to the NIH research budget. To make matters worse, many observers expect the emboldened anti-science crowd to unleash a number of draconian proposals to halt the study of human embryonic stem cells and roll back funding, even eliminating funding for the Bush stem cell lines. (In the anti-science push, this roll back could extend to non-human embryonic stem cells, as well as tissue specific cells (also referred to as adult stem cells.)

All is not lost, however, we have identified champions of patients on both sides of the aisle. We must redouble our efforts to reach out to our lawmakers to protect this potentially lifesaving and lifegiving field.



New clinical trial underscores ridiculous opposition talking point
It was announced at the beginning of this first week of 2011 that Advanced Cell Technology will be allowed to launch its second clinical trial (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage2.com/track/click?u=513b92eb0bf6c17f06cca149d&id=36abd5f237&e=3c3210452e) utilizing human embryonic stem cells targeting macular degeneration, an eye disease impacting 25-30 million people worldwide.

This trial helps spotlight one of the most ridiculous talking points ever devised by stem cell research foes: the tired bromide that embryonic stem cells have produced no treatments, with the implication that the field is somehow “junk science.” It is mind boggling how this argument is mindlessly repeated by opponents over and over. The scientific method we all learned in middle school taught us you can’t see scientific results until you do the experiment! The fact is that funding for hESCR has been most limited in the United States for more than a decade, and in spite of this, we now have three new clinical trials that FDA has allowed to proceed.

hESCs were only first isolated and cultured in 1998, and by any reasonable yardstick the field has advanced and is continuing to advance rapidly. How much further would we be if the research foes had not derailed substantial funding for all those years? And how much more time will we lose because of the federal lawsuit Sherley v. Sebelius?

It is a hugely complex and expensive process to move from the laboratory into clinical trials. Research foes play to the absence of widespread public understanding of basic science and the Herculean task of translating that science into medicine. Those of us who favor the undertaking of this science and its translation into medicine must be prepared to set the record straight when we read or hear such vacuous comments.

Of course, it is critically important for researchers to inform the public about their work and do so in a way that can be easily understood. This topic is the subject of a brilliant essay in the 2010 World Stem Cell Report by Dr. M. William Lensch titled “Science Education as Science Advocacy: A Personal View.” That essay can be downloaded at no charge here (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=4d53b91a76&e=3c3210452e).


Embryonic stem cells will measure up
Dr. John McDonald, a wonderful humanitarian and director of the International Center for Spinal Cord Injury at the Kennedy Krieger Institute in Baltimore, a longtime stem cell researcher and one of Christopher Reeve’s physicians, said in an essay at CNN Health that human embryonic stem cells and embryonic stem cells in general "are one of the greatest scientific tools of the 21st century." To read all of Dr. McDonald’s views see his commentary here (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=01c1ca89a3&e=3c3210452e).


New Endorsers- Stem Cell Action Coalition Surges
The Stem Cell Action Campaign surged to 52 members adding eight new endorsing groups: the Central Illinois Advocates for Lives Interrupted by Parkinson’s Support Organization (CALIPSO) (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=70691093ad&e=3c3210452e) , A. Alfred Taubman Medical Research Institute (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=23f63e27f3&e=3c3210452e), I Believe Incorporated (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=f70ecedd8f&e=3c3210452e), Cell Transplant Society (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=a61eb97245&e=3c3210452e), American Council on Science and Health (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage1.com/track/click?u=513b92eb0bf6c17f06cca149d&id=4cf14c9e53&e=3c3210452e), UK Stem Cell Network (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=0a19724ef7&e=3c3210452e), London Regenerative Medicine Network (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=0d70eaaae2&e=3c3210452e) and the Multiple Sclerosis Activism Foundation (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=8911a49c32&e=3c3210452e).

Join the Stem Cell Action Campaign
The Stem Cell Action Coalition serves as an engine to unite the pro-cures community. It recognizes that human embryonic stem cell research must be a national public health priority at all branches and levels of government, both federal and state, not only as a matter of the medical health of the individuals who comprise the United States, but also as a matter of national financial health.

Already joined by 52 organizations, the Coalition sponsors a web site www.stemcellaction.org (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage1.com/track/click?u=513b92eb0bf6c17f06cca149d&id=0a9977a79f&e=3c3210452e) and is actively engaged in social media. We urge you to become a follower of the Coalition on Twitter (@StemCellAction). In addition, the Coalition publishes this online bi-monthly newsletter “Stem Cell Action News”. This newsletter is disseminated to a database of more than 40,000.

To forge a permanent and unparalleled community of conscience and commitment, the Stem Cell Action Coalition seeks to recruit hundreds of organizations nation-wide.

Together we can speak with one voice, so our elected officials in the legislative and executive branches of government can no longer ignore our clearly spoken will: to protect and advance human embryonic stem cell research.

Please take action today:

Visit www.stemcellaction.org (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage1.com/track/click?u=513b92eb0bf6c17f06cca149d&id=d6d5407c27&e=3c3210452e) and send a letter to your Congressional representatives to support stem cell research.
Follow us on Twitter @StemCellAction.
Demonstrate your organization’s support for stem cell research by endorsing the Stem Cell Action campaign. This simple gesture serves as an expression of solidarity with the organizations and thousands of families already supporting this promising field of biomedical research and clinical development, with a shared goal to alleviate human suffering. Please send us your organization’s authorization to post your logo on the campaign web site. Send the authorization (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:mailto:alan@genpol.org?subject=I%27d%20like%20 to%20endorse%20the%20Stem%20Cell%20Action%20campai gn).
Make an online donation (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=3af46db821&e=3c3210452e) to the Stem Cell Action campaign. Proceeds will be used to advance the campaign.



To reach the Stem Cell Action coalition, please call toll free at 888-238-1423 or email our director of public outreach, Alan Fernandez at alan@genpol.org (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:mailto:alan@genpol.org).

Editorialhttp://sci.rutgers.edu/forum/mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://gallery.mailchimp.com/513b92eb0bf6c17f06cca149d/images/actnow.jpg (mhtml:%7B9C0D1C96-002D-4021-BCAD-E3E554C0C177%7Dmid://00000000/%21x-usc:http://genpol.us1.list-manage.com/track/click?u=513b92eb0bf6c17f06cca149d&id=48b7fd7870&e=3c3210452e)
Bernard Siegel
Executive Director
Genetics Policy Institute hope this works; tells about the progress on stem cell research funding from the gov'tment.

keeping on



Thanks for this update. I am unable to enter the links given, because the mhtml protocol is not recognised.

Yes, it's a great shame that Obama appears to be stifled in any way that the Republicans can think of, or invent. Probably one of America's greatest presidents, but unable to deliver to those who voted for him, and a thorn in the side of the opposition, who never believed in his policies anyway.

[keeping on]

Chris, still dspite everything going haywire, trials are going on roumd the world. We as a group hqve to stay involved. We will overcome and 2011 is going to be a magnificent year. Geron hopefully will provide treatments for acutes injuries. Wse has upped the dosage in his trials and he is set to start trials in the US. Many hosptials are remping up for trals here in the states. this not only will et our discussions to the point, but will provide hope or a cure. I belive this, though I'm contiually learining about deciept and scams in the theatre. We must focus on real trials and more discoveries this year. Also, I'm hoping that the trial for macular degeneration for elderly patients leads to a success for those people. this is very important.

keeping on

[keeping on]

don't quite understand this: http://www.desmoinesregister.com/article/20110116/NEWS10/101160331/-1/ENT05/Iowa-opens-new-debate-over-use-of-stem-cells; trials are starting fo rmacular degeneration adn these guys are saying they are starting and 5-10 years a treament might be availble, for one will respomd to hs artcle and tell them theya re full of --t. This is my response only. I'm doing because I'm tired of these oranizitions putting into the future in order to profligerate their jobs.

keepinmg on

[keeping on]

also, let the rest of the world contribute to these potential cures while the US participates in the unproductive discussion of right and wrong.

keeping on

[chris arnold]

don't quite understand this: http://www.desmoinesregister.com/article/20110116/NEWS10/101160331/-1/ENT05/Iowa-opens-new-debate-over-use-of-stem-cells; trials are starting fo rmacular degeneration adn these guys are saying they are starting and 5-10 years a treament might be availble, for one will respomd to hs artcle and tell them theya re full of --t. This is my response only. I'm doing because I'm tired of these oranizitions putting into the future in order to profligerate their jobs.

keepinmg on

This seems contradictory. As I understand it, there are current cases where optical damage has already been treated.

As to job continuance, if that is true, they should get in the queue. We are already seeing the effects of expenditure cuts on nurses and other front line carers.

[chris arnold]

also, let the rest of the world contribute to these potential cures while the US participates in the unproductive discussion of right and wrong.

keeping on

Again, the waters are being muddied by the establishment. Perhaps we should tell the senators that:

MANY OF THE STEM CELLS USED ARE NOT not from embryos.

We know that some are. The point is that most informed opinion is that ethical considerations are over amplified.

The congressional storm over this technical detail is yet another attempt to derail the reforms that a democratically elected president is trying to introduce. Basically the argument is that everyone should pay for medical treatment up front whether they can afford it or not, and taxes should be lowered at the expense of (publically funded) health research.

[keeping on]

Chris your vision is simialr to mine and many others; crystal clear. We must hope that the democorats can allow the USA to contribut to the field with the rest of the world. Irregardless, the science is moving alone despite what the politics of the day.

keeping on

[keeping on]

A good article about progress wirh stem cells; http://ph.news.yahoo.com/rtrs/20110118/tbs-pluristem-trials-7318940.html; many people could benefit from this as the macular degeneration trial will benefit millions. Excellent news for our community also.

keeping on

[keeping on]

here in another article on this advancelmet of stem cell treatment and it's approval by FDA to start trials. This could be big for this ailment as it leads to amputations and no real treatment for this. I wish the company and the patients well for this therapy. I get excited when I see real sciece moving forward; and this case is good for them and all. http://www.globes.co.il/serveen/globes/docview.asp?did=1000616505&fid=1725

keeping on

[chris arnold]

Chris your vision is simialr to mine and many others; crystal clear. We must hope that the democorats can allow the USA to contribut to the field with the rest of the world. Irregardless, the science is moving alone despite what the politics of the day.

keeping on
Keeping On, the problem appears to be (from a Brit's perspective) that a president in the US is sometimes hog tied as to achieving what he set out to do in the election run up. While not being given carte blanche to do as he feels fit, is a tenet of democracy, the stalling and smoke screens that the Republicans employ has effectively hobbled Obama, with as a consequence, his own supporters to become disenchanted.

[keeping on]

another clinical trials for als; http://www.globes.co.il/serveen/globes/docview.asp?did=1000617918&fid=1725; hopefully the trials for als patients will be successful for the dreaded disease. what a wonderful hope for those afflicted with this disease.

keeping on

[keeping on]

Interesting: http://www.globes.co.il/serveen/globes/docview.asp?did=1000617918&fid=1725; thank this group for their response.


keeping on

[keeping on]

Thank you for your inquiry and your interest in our research. We expect to initiate the spinal cord injury trial this quarter, but cannot predict at this stage how long
it will take to complete enrollment in the trial. We will be enrolling 12 patients, and each patient will be evaluated over a 12-month period following transplantation
in order to monitor and evaluate the safety and tolerability of the HuCNS-SC cells, the surgery and the immunosuppression, and to measure any recovery of neurological
function below the injury site. So, the trial will not be considered “complete” until 12 months after the 12th patient enrolled in the trial is dosed. However, we do
hope to be able to provide updates on the trial as it progresses.

As for our retinal program, we currently plan to file an IND to initiate a trial in age-related macular degeneration in 2012.

Regards,

Megan

Megan Meloni
Director, Media Relations & Corporate Communications
StemCells, Inc.

[keeping on]

http://scienceblog.com/42179/using-a-childs-own-stem-cells-to-repair-their-heart-looks-promising/ looks promising and God Bless the children;

[Jawaid]

What Novaryis started and which phase? For chronics?

[keeping on]

another clinical trials started for a terrible condition. http://www.stemcellresearchnews.com/absolutenm/anmviewer.asp?a=2469&z=9; they're coming fast and furious. It's coming folks, it's coming.

[keeping on]

another clinical trial for embryonicnstem cells to treat macular degeneration. Note, the success of the italian trial for corneal burns from chemical is mentioned. that trial was extemely successful.http://nutritiondietnews.com/embryonic-stem-cells-to-treat-age-related-amd/851789/ Let's hope that thsi trial ultimalty yields the same kond of outcome.

[swharris]

Okarma address to investors:
You'll need to sign in and go to 15:20 min in to hear SCI information.

http://jpmorgan.metameetings.com/webcasts/healthcare11/directlink.php?ticker=GERN

S.

[keeping on]

Another move forward. this time a differnt approach for ALS.
This is good, two differnt therapies for the ALS, disease. Hopefully, the trials will show some positve efffects for those patients.

keeping on

[ineedmyelin]

Advanced Cell Technology, Inc., this company is showing a lot of potential. check out these videos. i say this with guarded optimism but no one can deny that science is moving quick and in the right direction.


http://www.youtube.com/watch?v=3wv6lqv4vSE

[keeping on]

i received an e-mail replyu from Shepers regarding the Geron Trial. I asked when results will be given to the public. The response stated that it will be years for this project to get the results. the response said they will investigating the safety of the therapy. This we all know. I was disappointed in the results part. Again, my belief of a real therapy that we all can benefit from is becoming a timeframe that is not defined and will not affect me or many of us.

keeping on

[Leif]

i received an e-mail replyu from Shepers regarding the Geron Trial. I asked when results will be given to the public. The response stated that it will be years for this project to get the results. the response said they will investigating the safety of the therapy. This we all know. I was disappointed in the results part. Again, my belief of a real therapy that we all can benefit from is becoming a timeframe that is not defined and will not affect me or many of us.

keeping on
Letters received isn’t cures. Cures are long term dedicated follow-in.

[chris arnold]

i received an e-mail replyu from Shepers regarding the Geron Trial. I asked when results will be given to the public. The response stated that it will be years for this project to get the results. the response said they will investigating the safety of the therapy. This we all know. I was disappointed in the results part. Again, my belief of a real therapy that we all can benefit from is becoming a timeframe that is not defined and will not affect me or many of us.

keeping on
Rather looks that way. Disappointing after the lead up.

[GRAMMY]

i received an e-mail replyu from Shepers regarding the Geron Trial. I asked when results will be given to the public. The response stated that it will be years for this project to get the results. the response said they will investigating the safety of the therapy. This we all know. I was disappointed in the results part. Again, my belief of a real therapy that we all can benefit from is becoming a timeframe that is not defined and will not affect me or many of us.

keeping on

This Phase 1 trial is purely for safety. They've just started recruiting patients and they wait 30 days between patients. A lot of time will pass before the patients responses are made public. They will need time to work with any adverse events (if they should happen) and be watching for any unwanted symptoms, etc... It may take quite some time for safety concerns to develop. The first stop gap for the first patient won't even happen until the end of this year. It's a very long timeframe if you've ever analyzed it out. In addition to that they are injecting "complete" injuries.

They've just barely started Phase 1 "safety".
(Phase 1 data should near completion around October 2012, depending when the last patient is enrolled.)

(It would be silly to announce a miracle cure after the first 2 people are injected and then have them die from complications or have cell rejection 9 or 10 months later...They just can't prove human safety in a petri dish. Effectiveness is proven in Phase 2-3-4 anyway...)

In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase IV clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

With the given timeframes, many people resort to medical tourism and just have unproven cells injected in other countries when they get into a hurry.

[jhorn4012]

This Phase 1 trial is purely for safety. They've just started recruiting patients and they wait 30 days between patients. A lot of time will pass before the patients responses are made public. They will need time to work with any adverse events (if they should happen) and be watching for any unwanted symptoms, etc... It may take quite some time for safety concerns to develop. The first stop gap for the first patient won't even happen until the end of this year. It's a very long timeframe if you've ever analyzed it out. In addition to that they are injecting "complete" injuries.

They've just barely started Phase 1 "safety".
(Phase 1 data should near completion around October 2012, depending when the last patient is enrolled.)

(It would be silly to announce a miracle cure after the first 2 people are injected and then have them die from complications or have cell rejection 9 or 10 months later...They just can't prove human safety in a petri dish. Effectiveness is proven in Phase 2-3-4 anyway...)

In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase IV clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

With the given timeframes, many people resort to medical tourism and just have unproven cells injected in other countries when they get into a hurry.
Grammy: thank you for clarifying Phases of clinical trials. What i
would like to know is when will clinical trials for chronics start? I have
read there starting one up in New Zealand using Dr. Lima's approach
of using nose cell OEC stem cells with intensive physical therapy
only asking at this time candidates be T level and complete. New Zealand
is awaiting approval that was in March. I received info from apparlyzed forum
in February 2011.

[jhorn4012]

just received hopeful if it would work for chronics

http://www.ninds.nih.gov/news_and_events/news_articles/taxol_reduces_SCI_scarring.htm

[ineedmyelin]

looks like for acutes only, chronics would already have scar tissue issues........

[keeping on]

ineedmyelin, Wise says that scar tissue is not the same as these other views from researchers on this. If , I'm not mistaken, Wise, seems to feel that he can handle the "scar tissue" scenerio. I don't know, buit it is confusing with the different views on it.

[djas57]

My question is where, when, which one & finally how much.
I am on these forums for a long time, keep reading the same things again & again, the cure for SCI isnt possible in our life time unless you take the risk like the title of this post.

[east dragon]

My question is where, when, which one & finally how much.
I am on these forums for a long time, keep reading the same things again & again, the cure for SCI isnt possible in our life time unless you take the risk like the title of this post.
Everyone was tired!

[jhorn4012]

Christopher Reeves site shows article of a chronic in a clinical trial in 2009 for electrical spinal cord stimulation and locomotor training. Person was injured in 2006 c7 t1 and is now able to move toes, feet, ankles and legs on command. Is able to stand supported. Panamain jockey goes to Switzerland for stem cell clinical trial. Jockey injured in 2010 in
horserace in U.S. was denied acceptance in Geron trials?

[c473s]

Christopher Reeves site shows article of a chronic in a clinical trial in 2009 for electrical spinal cord stimulation and locomotor training. Person was injured in 2006 c7 t1 and is now able to move toes, feet, ankles and legs on command. Is able to stand supported. Panamain jockey goes to Switzerland for stem cell clinical trial. Jockey injured in 2010 in
horserace in U.S. was denied acceptance in Geron trials?

The Jockey did not meet the inclusion criteria.

[jhorn4012]

The Jockey did not meet the inclusion criteria.
Creditable websites said the hospital and the family both asked to have their son included
in Geron embryonic stem cell trial within 14 days of his injury on track. One paper hinted jockey may bave had a TBI.

[lunasicc42]

why does your post have a smiley face of this news...? Sorry, please explain

[jhorn4012]

why does your post have a smiley face of this news...? Sorry, please explain

This is the headline from stemcellsandatombombs blogsite
and his blog will give you more info why I used smiley face on my
thread. Let me know if you have problem finding his blogsite.

[GL]

I want to be a Guinea Pig I got nothing to lose
:thumbsup: GL

[jhorn4012]

I found this from u2fp.org site and the following url: http://clinicaltrials.gov/ct2/show/NCT01231893?term=nct01231893&rank=1

My question is will this be something that will exclude chronics that have metal discs replacing SCI?

[c473s]

Creditable websites said the hospital and the family both asked to have their son included
in Geron embryonic stem cell trial within 14 days of his injury on track. One paper hinted jockey may bave had a TBI.
TBI would have excluded him as would several other criteria. The 14 day window is not the sole criteria such as the size of the lesion. I lean toward TBI because the screening for the lesion and other issues doesn't occur until the patient is at the hospital where the procedure will take place.

[jhorn4012]

TBI would have excluded him as would several other criteria. The 14 day window is not the sole criteria such as the size of the lesion. I lean toward TBI because the screening for the lesion and other issues doesn't occur until the patient is at the hospital where the procedure will take place.

I received email from stemcellsatombomb (Dennis) and he has all of his immigration paperwork completed and is on his way to Switzerland for clinical trial and the family will be giving updates of his condition after he receives whatever he will be getting in clinical trial. I guess the family doesn't realize being in a clinical trial may mean no info given to public source. But that didn't stop the student in Georgia from releasing to the local news he was the first person to receive embryonic stem cell.

[Patty41]

I want to be a Guinea Pig I got nothing to lose
:thumbsup: GL

Me too, Judy!! :high5:

[jhorn4012]

Me too, Judy!! :high5:

My daughter said the same thing too!!!!!

[c473s]

I received email from stemcellsatombomb (Dennis) and he has all of his immigration paperwork completed and is on his way to Switzerland for clinical trial and the family will be giving updates of his condition after he receives whatever he will be getting in clinical trial. I guess the family doesn't realize being in a clinical trial may mean no info given to public source. But that didn't stop the student in Georgia from releasing to the local news he was the first person to receive embryonic stem cell.
The restrictions are about releasing details of the procedure. There is no restriction on stating you were in the trial although Geron would prefer they did not do that.

[Wise Young]

I found this from u2fp.org site and the following url: http://clinicaltrials.gov/ct2/show/NCT01231893?term=nct01231893&rank=1

My question is will this be something that will exclude chronics that have metal discs replacing SCI?

jhorn,

Many of the trials require current MRI scans of the spinal cord. We required this also of patients in the ChinaSCINet CN102B trial and had to turn down some patients because of this. Much depends on the metal that is put in and whether it has any iron/steel in the metal. MRI is affected by iron and other paramagnetic materials. Paramagnetic means materials that are affected by magnet fields. http://en.wikipedia.org/wiki/Paramagnetism

We got permission of our spinal cord injury investigators to waive the requirement for current MRI scans as the requirement for entry into the trial. Some doctors may not be willing to do this because they want to make sure that the MRI scan shows what they are operating on and they don't want to have any surprises when they operate, such as a large syringomyelic cyst or disc compressing the spinal cord.

On the other hand, even our current neurosurgeons are feeling sufficiently comfortable with the procedure that they are willing to considering doing the surgery without having a clear MRI of the injury site beforehand. By the way, the presence of metallic plates and screws does not rule out a CT scan and clear images of the bone and spinal canal. Needless to say, it would be better to have an MRI.

Wise.

[jhorn4012]

jhorn,

Many of the trials require current MRI scans of the spinal cord. We required this also of patients in the ChinaSCINet CN102B trial and had to turn down some patients because of this. Much depends on the metal that is put in and whether it has any iron/steel in the metal. MRI is affected by iron and other paramagnetic materials. Paramagnetic means materials that are affected by magnet fields. http://en.wikipedia.org/wiki/Paramagnetism

We got permission of our spinal cord injury investigators to waive the requirement for current MRI scans as the requirement for entry into the trial. Some doctors may not be willing to do this because they want to make sure that the MRI scan shows what they are operating on and they don't want to have any surprises when they operate, such as a large syringomyelic cyst or disc compressing the spinal cord.

On the other hand, even our current neurosurgeons are feeling sufficiently comfortable with the procedure that they are willing to considering doing the surgery without having a clear MRI of the injury site beforehand. By the way, the presence of metallic plates and screws does not rule out a CT scan and clear images of the bone and spinal canal. Needless to say, it would be better to have an MRI.

Wise.

Thank you Dr.Young,
I have heard mixed views on MRIs and titanium. All doctors said in Texas is "NO" because they are not sure what is metal content of screws and netting that were used in corpectomy.
I believe I have all that info from neurosurgeon's report (which had been received by Baylor doctors before we flew in) during the procedure and notes made before/during and after when they removed head traction and replaced with a neck collar after surgery to keep her from moving her neck from side to side. Last year we had a CT scan done and everything according to Baylor dr. looked ok.

[jhorn4012]

The restrictions are about releasing details of the procedure. There is no restriction on stating you were in the trial although Geron would prefer they did not do that.
c473s:
I will post when I receive any info from family through Dennis T.

[Rivera]

Hi Dr Wise:

we met in Phoenix, AZ in the last "Learning 2 Walk" seminar. I have an 11 year old son with incomplete SCI whose had a chronic damage for the last 3 years. You mentioned that Shriner's Philadelphia was going to start some "Stem Cell Clinical Trials" hopefully this year. Could you expand some more on which types of trials and how are things going with these trials, in case they've started already?

Also, how do these trials compare to the "Autologous Stem Cells for Spinal Cord Injury (SCI) in Children" being recruited in Houston right now?

Thanks

[Rivera]

Hi Dr Wise:

we met in Phoenix, AZ in the last "Learning 2 Walk" seminar. I have an 11 year old son with incomplete SCI whose had a chronic damage for the last 3 years. You mentioned that Shriner's Philadelphia was going to start some "Stem Cell Clinical Trials" hopefully this year. Could you expand some more on which types of trials and how are things going with these trials, in case they've started already?

Also, how do these trials compare to the "Autologous Stem Cells for Spinal Cord Injury (SCI) in Children" being recruited in Houston right now?

Thanks

Thanks Grammy, I hope Dr Wise remembers us. I'll be waiting for your answer

[Wise Young]

Hi Dr Wise:

we met in Phoenix, AZ in the last "Learning 2 Walk" seminar. I have an 11 year old son with incomplete SCI whose had a chronic damage for the last 3 years. You mentioned that Shriner's Philadelphia was going to start some "Stem Cell Clinical Trials" hopefully this year. Could you expand some more on which types of trials and how are things going with these trials, in case they've started already?

Also, how do these trials compare to the "Autologous Stem Cells for Spinal Cord Injury (SCI) in Children" being recruited in Houston right now?

Thanks

Rivers,

We are pushing hard to get the phase 2 trials finished in Hong Kong and China because the applications for trials in the U.S. depends on the data that we get from the trials in Hong Kong and China.

In terms of trials in the U.S., we are still aiming for starting a phase 2 trial in Brackenridge in early 2012, a phase 3 trial in other centers in the U.S. in mid-2012, and a phase 2 trial for kids in late 2012. This is for umbilical cord blood and lithium.

Wise.

Wise.

[Christopher Paddon]

Thanks Wise for keeping us so up to date.

Does finishing phase 2 trials mean that there has to have been atleast some return of sensation or function because phase 2 is for efficacy, if only a tiny amount?

[Christopher Paddon]

By the way those possible dates are fantastic and I'm sure everyone on carecure appreciates the work you and the others do to keep these clinical trials going.

[lunasicc42]

yes, much appreciated wise

[2TiRods]

Rivers,

We are pushing hard to get the phase 2 trials finished in Hong Kong and China because the applications for trials in the U.S. depends on the data that we get from the trials in Hong Kong and China.

In terms of trials in the U.S., we are still aiming for starting a phase 2 trial in Brackenridge in early 2012, a phase 3 trial in other centers in the U.S. in mid-2012, and a phase 2 trial for kids in late 2012. This is for umbilical cord blood and lithium.

Wise.

Wise.

Dr. Wise.

Any chance of getting or looking at Santa Clara Valley Medical Center in California to help with the trial? They are part of Geron's trial working with Stanford University.

[rexio]

http://www.aksonaxis.org.pl/pdf/Brain_OEC.pdf



by dr. tabakow in wroclaw, poland

[KIM]

Bien.

[lynnifer]

Am I misunderstanding something or why is anyone fooling around with ensheathing glia anymore? Didn't Dr Huang do a bunch for thousands of cash .. I know he didn't document it as in a clinical trial .. but seemingly no one had any fabulous results from it either.

[lunasicc42]

Am I misunderstanding something or why is anyone fooling around with ensheathing glia anymore? Didn't Dr Huang do a bunch for thousands of cash .. I know he didn't document it as in a clinical trial .. but seemingly no one had any fabulous results from it either.

this is kind of like a question that I have.... Why are some societies or doctors attempting to replicate what has already been done in other labs and had very limited results?
Like that trial in new zealand to do exactly what dr. Lima has already done and had very limited results... Why re-invent the "square wheel "?

[lunasicc42]

Ya, the kind of "active Treatments " that don't work?

[paolocipolla]

Am I misunderstanding something or why is anyone fooling around with ensheathing glia anymore? Didn't Dr Huang do a bunch for thousands of cash .. I know he didn't document it as in a clinical trial .. but seemingly no one had any fabulous results from it either.

As I know this is actually a very well done study. Nothing to do with Lima and Huang
I believe it opens the way to find out what the real potential of the OECs is.

I am not a fan of the OECs BTW (for what it worth my opinion), but the problem with the studies done by Lima etc., in my modest opinion, is the very questionable metodolgy.

According to the PDF one patien out of three went from asia A to C. One went from A to B.
All had some mesurable improvements.

The three control patients that recived just the PT didn't report any improvement as I read.

If we can finally establish what is the real potential of the OECs, it would be a real progress in my opinion.

Prof. Raisman said few months ago that since the OECs are very difficult to grow in sufficient quantity for filling the enjury site it could be cosidered to combine OECs with a scaffold.

I hope that, if this strategy has a real potential, it will be tested on humans without unnecessary delay due to regualtory issues or funding problems.

[paolocipolla]

http://www.aksonaxis.org.pl/pdf/Brain_OEC.pdf



by dr. tabakow in wroclaw, poland

Thank you for posting that.

[e.t.]

Thank you, Paolo. Excellent explanation.

Congratulation dr. Tabakov

What next?

[Christopher Paddon]

this is kind of like a question that I have.... Why are some societies or doctors attempting to replicate what has already been done in other labs and had very limited results?
Like that trial in new zealand to do exactly what dr. Lima has already done and had very limited results... Why re-invent the "square wheel "?

I have been told they are doing OEG just to satisfy safety regulations. Then they are moving on to bone marrow stem cells plus combination with decerin or something.