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Thread: SCINetUSA Website

  1. #51
    Quote Originally Posted by CAS View Post
    It depresses me to think that some people critics of others for not donating anything towards a eventual cure, although I do myself.

    I do not think that any of you would not know of others who are paralyzed s as well who are unable afford any donation as merely serving financially to place food on the table an maintaining a roof over their heads is a big ask in it’s self.

    But I am surprise that you talk of the costs in the US which is understandable, but then why not use the funds to develop a clinical trial in another country where you get more value for your dollar?

    I am not sure but I think that Australia and the US FDA have now the same standards and approval in one is the same in the other.

    Therefore Dr Wise could the US get approval of a Clinical trial but carry the trial in Australia where the US dollar would have a larger effect in getting a cure developed and moving a cure for both countries forward?

    I also think people give up supporting any causes because of the constant barrage of telemarketers and others that appear not achieve anything significant for ten or more years.

    To get the general public to support and donate a cure would be to show that things are progressing forward on a yearly basis, like the rats then to human trials with or without success. Within a five year turn-a-over. Otherwise it appears nothing more than a scam for those marketing the cure.

    CAS,

    Perhaps I can relate the history of ChinaSCINet and SCINetUSA. I formed ChinaSCINet in 2005 to do clinical trials of promising therapies in chronic spinal cord injury. We spent several years training all the centers to carry out standard neurological examinations and other outcome measures, prepared them to do clinical trials, and reviewed all of the most promising therapies of spinal cord injury. The money for the trials were raised in Hong Kong through the hard work of the HKSCIFund, which solicited donations from people in Hong Kong.

    We reviewed all the therapies that were available at the time. For example, we considered embryonic stem cells (ESC), neural stem cells from aborted fetuses, bone marrow stem cells, olfactory ensheathing glial cells from aborted fetuses and the nose, Schwann cells, and HLA-matched umbilical cord blood mononuclear cells. We looked at all the combination therapies that have been reported to be beneficial.

    For example, little convincing evidence suggested beneficial effects of fetal or embryonic stem cells that are not HLA-matched to the recipients. For example, despite the substantial experience of several of our surgeons in China in transplanting olfactory ensheathing glia, we were not convinced that the treatment was restoring motor function to patients with chronic spinal cord injury.

    In some cases, the cells were simply not available. For example, I spoke to Woo Suk Hwang several times about cloning of embryonic stem cells for the trials. It turned out that he had falsified data concerning the cloning of human cells that he published. Likewise, we looked carefully at the work of Lima and the possibility of growing cells from the nasal mucosa of the person. We were not convinced that the cells could be grown routinely to treat large numbers of patients.

    In 2006, we had only two sources of cells that were available in quantity and could be produced under GMP (good manufacturing practice) conditions: bone marrow stromal cells and umbilical cord blood mononuclear cells. We chose the latter for the following reasons:
    1. Several independent laboratories had reported that umbilical cord blood cells improved recovery when transplanted into the spinal cord of rats and other animals after spinal cord injury.
    2. Umbilical cord blood cells are available for cord blood banks that have enough units so that the cells can be HLA-matched. Cord blood has been used to treat over 20,000 patients around the world since 1988.
    3. The cells could be isolated, produced, and delivered to the clinical trial centers for a reasonable cost. We chose to use Stemcyte, the world's largest and best commercial umbilical cord blood company to supply the cells.

    We discovered that lithium strongly stimulates umbilical cord blood cells to proliferate (make many cells) and also to produce three neurotrophins that are known to stimulate regeneration in the spinal cord: NGF, NT-3, GDNF. In animal experiments, we found that lithium given to the animals will cause transplanted cells to proliferate and to produce neurotrophins in the spinal cord.

    It is difficult to get umbilical cord blood cells for rats or mice. We consequently used the blood of newborn rats or human umbilical cord blood. These cells are immune-rejected within 2-3 weeks in rat spinal cord unless we used cyclosporin or some other kind of immunosuppressive drug. It turned out that cyclosporin or FK506 (another immunosuppressive drug) both completely blocked the effects of lithium on umbilical cord blood and the cells did not produce neurotrophins in response to lithium. Therefore, we were not able to test the combination therapy in rats.

    Based on evidence that umbilical cord blood cells alone are beneficial in animal models of spinal cord injury and evidence that lithium strongly stimulates umbilical cord blood cells to produce neurotrophins known to activate regeneration in the spinal cord, we proposed to test the combination of the two therapies in the following clinical trials.
    • CN100. This is an observational trial to demonstrate that the clinical trial centers can collect and deliver the data.
    • CN101. This is a phase 1 trial to show the safety and feasibility of giving 6 weeks of oral lithium to patients with spinal cord injury.
    • CN102A. This is a phase 2 trial to determine whether a 6-week course of oral lithium has any effect on neurological scores, pain, and spasticity in people with chronic spinal cord injury. The trial found that lithium significantly reduced neuropathic pain in people with chronic spinal cord injury.
    • CN102B. This is a phase 2 trial to asses 4, 8, and 16 ┬Áliter injections of umbilical cord blood mononuclear cells to the spinal cord, then cell transplants with a single bolus of methylprednisolone (which we and others have shown to increase survival of transplanted cells), and then the cell transplants, methylprednisolone, and a 6-week course of lithium. This trial is underway in Hong Kong. We are recruiting the 20 patients needed to carry out the trial. We have also completed validating the cells for transplantation. The recruitment of patients for the trial is turning out to be slower than expected. However, we have recently made some changes in the protocol that may speed up recruitment. Furthermore, we have received word that the trial has been approved in China. We are working hard now to get the trial going in China in parallel with the trial in Hong Kong.
    • CN103. If CN102B shows that the cell implants can be safely done without any adverse effects and possibly with beneficial effects, we will go ahead to do this trial of 400 patients with chronic spinal cord injury. All the patients will receive the umbilical cord blood mononuclear cell transplants.


    SCINetUSA started in February 2009. We started the U.S. network because many people in the United States had requested to go to China to participate in the clinical trials there. I thought that this was inappropriate and therefore started the trials in the U.S. It needs to be done in the United States anyway in order to get FDA approval of the therapy. Furthermore, it is just wrong that we ship Americans overseas to participate in clinical trials of therapies that are developed in the United States. Our plan is to initiate a US103 trial that would parallel CN103. In the U.S., this trial would require about 240 patients, i.e. four groups of 60 patients that receive rehabilitation alone, rehabilitation and lithium alone, rehabilitation and cell transplant alone, and rehabilitation, cell transplant, and lithium. We have held four meetings of the investigators of 8 leading spinal cord injury centers in the United States and have agreed on all aspects of the protocol except for the rehabilitation part. We are planning a meeting next week on the subject to see if we can come up with a final plan that all the centers could accept.

    Regarding costs, we estimate that CN103 in China will cost about US$6 million. US103 will cost about US$24 million. We are raising the money for these trials from every source possible. One funding source that I would like to develop for clinical trials in the United States is for each family with spinal cord injury to donate $1 per day to the U.S. trials, called SCINetUSA. If people can give that much, we would be very grateful. If people give less, we would be no less grateful. If 10,000 families were to give a dollar a day, this would provide $3.65 million per year. If 100,000 families gave this amount, ti would be $36.5 million per year.

    Our goal is not to test umbilical cord blood cells and lithium as the one and only therapy for spinal cord injury. It is just the first of many therapies that we hope to test in ChinaSCINet and SCINetUSA. If we show that cord blood cells and lithium improve function in people with chronic spinal cord injury and we were able to take this combination therapy through Phase 1, 2, and 3 clinical trials with $6 million over 6 years, this would not only break a record but would turn the heads of every major pharmaceutical, therapeutic, and biotech company in the world. It currently costs an average of over $1 billion to take a therapy from discovery to market.

    The networks will be continuing to test the most promising therapies of chronic spinal cord injury in the coming years. The speed at which these tests will be done will increase as we gain more experience and become better funded. At the present, we are solving problems that have never been tackled before. We are breaking new trails in the jungle. This is the first time anybody, to my knowledge, has tested a combination cell transplant and drug therapy. Once this has been done once, it would be relatively straightforward to do it again with other cells and drugs.

    I apologize for the length of this discourse but given the questions that you and others were asking, I am trying to clear up misunderstandings about what these two clinical trial networks are trying to accomplish. Please note that JustADollarPlease.Org is intended to support SCINetUSA.

    Wise.
    Last edited by Wise Young; 07-09-2010 at 11:08 PM.

  2. #52
    Quote Originally Posted by SharonD View Post
    I realize this must be quite frustrating, repeating to us the costs associated with trials and the need for funding. Most of us want to help and can do a much better job at promoting "Just One Dollar"

    Will there be any time on July 22nd to have a discussion about funding? Status of NJ budget cuts? How we can restore that funding? I will be there and Random is planning to attend, she seems to be our best resource for information and who's who.
    SharonD,

    First, I want to give you a huge electronic hug and thank you for all your supporting words.

    Second, usually at the Open House meetings, the group questions end around 7:30-8:00 pm but I have stayed to answer the questions of individuals, often staying till 10-11 pm at nights. From this month on, I thought that we would try something different. On July 22, I will order take-out dinner for those people who want to stay and donate money or help the Center raise money for spinal cord injury research. While we often talk at Open Houses about the funding situation, we seldom deal with the subject systematically or talk about what people can do to help. This year is the hardest year for funding in memory. With all the drastic cuts by the state of New Jersey, the drying of funds from all the foundations (The Reeve Foundation is not giving out any grants), the cutting back of NIH, and the unwillingness of companies to support spinal cord injury research, we are having a hard time at the Center. So, if there are people who are interested in staying for dinner, we will make it a fundraising dinner.

    Third, it seems to me that a lot of people are assuming that clinical trials are not happening because there are no promising therapies. This is not true. Many promising therapies are making animals walk but there is no money for clinical trials, especially in times of recession. I have been pushing the government, industry, and private sector to fund clinical trials for over two decades. It is often been lonely being out there on my own. I believe that if the spinal cord injury community does not support the clinical trials, they won't happen. Perhaps this is all right with some people but it is not all right with me. So, I will keep pushing and am very glad for your company and those of others.

    Wise.

  3. #53
    Dr. Young, thank you for explaining (once again) the details involved with the SCINetUSA clinical trials. Your patience and drive to help us understand and to get folks involved is extraordinary!
    This detailed explanation would be a great addition to the JustADollarPlease site. I think people are more apt to donate to a cause they can wrap their head around. The history and break-down of the trial phases was very informative. I know you've explained all this before, but having this amount of detail in one place on JustADollarPlease will help convince potentail donors who are on the fence.
    Thanks again.

    Chuck

  4. #54
    Quote Originally Posted by Wise Young View Post
    Yes, Kivi66. You seem to believe that there is no evidence that umbilical cord blood mononuclear cells and lithium improve functional recovery in animals. I have posted here many times the papers that multiple investigators have published showing that umbilical cord blood cells improve walking in animals with spinal cord injury. Likewise, lithium alone has been shown to improve recovery in animals with spinal cord injury. Have you read any of the papers?

    By the way, much published evidence supports the beneficial effects of methylprednisolone on spinal cord injury, including walking cats, dogs, and rats. Three clinical trials involving hundreds of patients showed that methylprednisolone improved recovery in humans. I know many people who probably would not be walking today if not for methylprednisolone. I don't understand. Why are you so negative, not just about methylprednisolone but about umbilical cord blood and lithium as well?

    Wise.
    Dr.Wise,It's not negativity or positivity,but criticism.Not that I have right to criticise you,just possibility,provided by you,I realise that.And what I want that you provide too is evidence of success,achieved by you or your people in restoration structure and functionality some relatively big mammal's chronically damaged spinal cord.Without such evidence all human trial's expectations not more than speculation.And I have two questions.When do you suppose will be published work done by Kai Liu and whether you planning practical appliance of this finding in human trials? Thank you.
    Last edited by kivi66; 07-10-2010 at 04:59 PM.

  5. #55
    Senior Member lunasicc42's Avatar
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    Oh damn... There has been talk about the specifics of the upcoming chinascinet trials and usa trials all over the place and for months now... Just wondering, what exactly hasn't already been explained or discussed?
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  6. #56
    Quote Originally Posted by lunasicc42 View Post
    Oh damn... There has been talk about the specifics of the upcoming chinascinet trials and usa trials all over the place and for months now... Just wondering, what exactly hasn't already been explained or discussed?
    lunasicc42, it's your inalienable human right to be satisfied with what has been already explained.I don't infringe upon that.

  7. #57
    Senior Member lunasicc42's Avatar
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    No, say what exactly hasn't been explained. Whats your question ?
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  8. #58
    Well,you know,it to some extent depends on Dr.Wise's replies.He has talent not to answer on questions by answering on them.

  9. #59
    Senior Member lunasicc42's Avatar
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    thats alot of words to say 'nothing'. You have no legitimate questions that haven't already been answered somewhere
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  10. #60
    Quote Originally Posted by Wise Young View Post
    SharonD,

    First, I want to give you a huge electronic hug and thank you for all your supporting words.

    Second, usually at the Open House meetings, the group questions end around 7:30-8:00 pm but I have stayed to answer the questions of individuals, often staying till 10-11 pm at nights. From this month on, I thought that we would try something different. On July 22, I will order take-out dinner for those people who want to stay and donate money or help the Center raise money for spinal cord injury research. While we often talk at Open Houses about the funding situation, we seldom deal with the subject systematically or talk about what people can do to help. This year is the hardest year for funding in memory. With all the drastic cuts by the state of New Jersey, the drying of funds from all the foundations (The Reeve Foundation is not giving out any grants), the cutting back of NIH, and the unwillingness of companies to support spinal cord injury research, we are having a hard time at the Center. So, if there are people who are interested in staying for dinner, we will make it a fundraising dinner.

    Third, it seems to me that a lot of people are assuming that clinical trials are not happening because there are no promising therapies. This is not true. Many promising therapies are making animals walk but there is no money for clinical trials, especially in times of recession. I have been pushing the government, industry, and private sector to fund clinical trials for over two decades. It is often been lonely being out there on my own. I believe that if the spinal cord injury community does not support the clinical trials, they won't happen. Perhaps this is all right with some people but it is not all right with me. So, I will keep pushing and am very glad for your company and those of others.

    Wise.

    Wonderful! I look forward to seeing you on July 22nd and I am speaking with Jim and Patricia on what we can do to help with fundraising, create a committee, hopefully getting the SCI community involved. I have also communicated with Susan Howley and gathered some of her thoughts about the budget cuts. We can discuss on the 22nd. As always, thank you for your hard work.

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