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Thread: Stephen Davies Update

  1. #211
    Senior Member poonsuzanne's Avatar
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    Quote Originally Posted by Stephen Davies
    Hi Suzanne,
    Yes, given sufficient funding and supporting data from my lab and other top labs we are collaborating with, we are shooting to go to clinical trial in 2 to 3 years. The first phase will most likely be clinical trials with Decorin alone as it is already available at the GMP grade. We are currently working on developing GMP grade human GDA BMPs in collaboration with two different top US stem cell research groups. Usually it is difficult to predict how long it will take to develop the human form of cells to GMP grade for clinical trial, however given our initial preliminary results so far, I am pleased to say we are on track. The final goal is to combine both therapies for clinical trial. It is possible we could accomplish this in 3 years if not before.

    Some background information about me:
    I am a british citizen and I have been in the field of CNS regeneration since 1990. I studied for my PhD in CNS regeneration neuroscience with Geofffrey Raisman in London where I first became interested in CNS scar formation and was a postdoctoral fellow with Jerry Silver in Cleveland Ohio where I designed experiments that showed that scar tissue presented a major barrier to growing adult axons after SCI at acute and chronic (up to 9 months) stages after injury. I started my own lab and SCI research program as an Assistant Professor at Baylor College of Medicine, Houston TX in 2000 and was head hunted from Baylor to the new Anschutz Medical Campus at University of Colorado Denver in February this year. I am pleased to say my research team won the 2006 ASIA award for breakthough SCI research for our work with decorin and suppression of spinal scar formation.

    Why has it taken 17 years before I am willing to state that I am working on therapies that are promising enough to take to clinical trial? Because it took 17 years of hard basic science trying to understand the mechanisms of why CNS regeneration fails first and then working out which molecules and cells such as decorin and GDAs had the best chance of success in SCI repair. Those that know me know I am not an overly cautious type of person. I have motorcycle and race car licenses and even bungy jumped in New Zealand in my youth during a solo "round the world" backpacking trip. However I am not one to take cavalier chances with other peoples well being, especially those suffering from terrible SCI related disabilities.

    I look forward to hearing from you Suzanne and anyone else on the forum who would like to support our SCI research.

    Stephen Davies.
    Dr. Davies,

    Thanks for sharing all of your background information, they are sounding and interesting. Moreover, it is comforting to hear that you are confident to bring the SCI therapies "Decorin & GDA BMP cells" to clinical trials within the next 3 years, although it took you 17 years of hard work to identify and develop them.

    My personal donation through wire transfer has been made from Canada and it should arrive in your office by the end of next week.

    Once again thank you so much for being a passionate and tireless scientist who devotes working on our side!!!

    Suzanne
    Last edited by poonsuzanne; 11-16-2007 at 11:40 PM.
    Suzanne

  2. #212
    Sorry for your loss. God Bless

  3. #213

    dr Davies,

    Quote Originally Posted by Corinne Jeanmaire
    To all Sci patients and carecure members,
    I think it's great that many of us, sci patients have decided to contribute and make a donation to a sci fundation or directly to a lab or a research project. Reading Schmecky's report, I think there is enough material to motivate many more people to do something and also give money.
    So, I am just thinking. Could we not start an action to get other people to give too. Many people would not give money to a fundation or an association, because they are not sure of what is done with the money. In this case, we have a reputed scientist with a serious research project which is both innovative and promising. Well, no firm promise for a result, but enough arguments to convince us.
    It could be a simple action like emailing the description of the project and a highlight of what is at stake to all people we know and ask them to contribute. Or it could be something bigger, with the media ? Well, American members pls comment. And of course, who says that only Dr Davies research should get money? We could have various projects like this, and also include other research projects as long as they have a clear serious scientific background and they target a quick progress and switch to human clinical trials within 2/3 years (let's go for an ambitious target!).
    Why would this work better than any other fund collection so far ? well, the voice of patients might be convincing and the target is getting concrete enough. It's like you would be more enclined to give to a kid you know to get him to school or get food rather than giving to big fund when you do not know for sure what's going to be done with your money.
    We are now really a this fantastic time when it's not anymore a question of IF there will be a cure for spinal cord injury but there is a when. Realistic Schmecky is the living proof of it !!
    What do you all think of doing something more to get much much more money to DEDICATED sci research projects ?
    Just an idea...
    Dr Davies,
    As Suzanne Poon said 'thanks for being a scientist on our side". With regard to the financial aspect, I still think we do not use our strength enough and go too much for small and individual moves and contributions. I was wondering what you, Dr Davies, think of the above suggestion to 'organize' financial flows to your lab to enable clinical trial within 3 years. Does this sound realistic and useful to you ? If so, I assume your upcoming publication would be the starting point of any action towards the public and/or towards any institution? (you plan to publish in January 2009, is that right).
    thanks.
    best regards. Corinne

  4. #214
    Senior Member poonsuzanne's Avatar
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    Quote Originally Posted by Corinne Jeanmaire
    Dr Davies,
    As Suzanne Poon said 'thanks for being a scientist on our side". With regard to the financial aspect, I still think we do not use our strength enough and go too much for small and individual moves and contributions. I was wondering what you, Dr Davies, think of the above suggestion to 'organize' financial flows to your lab to enable clinical trial within 3 years. Does this sound realistic and useful to you ? If so, I assume your upcoming publication would be the starting point of any action towards the public and/or towards any institution? (you plan to publish in January 2009, is that right).
    thanks.
    best regards. Corinne
    Corinne,

    This is one of the ideas we should consider:-

    Maybe someone with a core group of volunteers should help Dr. Davies to set up a foundation which is specially dedicated to raise funds for his research work. What would you think?

    Suzanne

    ****************

    Oh, I am sorry I might be wrong!! Setting up a foundation is a lot of work and time consuming. But I am hoping to see that some people will lead in the fund raising efforts for Dr. Davies in a consistent and urgent manner.
    Last edited by poonsuzanne; 11-18-2007 at 07:15 PM.
    Suzanne

  5. #215
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    Dr. Davies, thanks for your response. I can understand your concerns about some of my questions. All the best to you and your lab in this mission for a cure.

  6. #216
    Dr. Davies,

    What do your instincts tell you about db cAMP? Thanks in advance.


    Targeting Neurite Growth Inhibitors to Induce CNS Regeneration

    "In vivo: To test the possibility that an increase in cAMP is sufficient to induce subsequent dorsal column regeneration, the cAMP analog dibutyrl-cAMP was injected directly into L5 dorsal root ganglia [45]. This resulted in extensive regeneration of dorsal column axons when they were lesioned at T7 one week later by a bilateral scissor cut. In addition, 1 day and 1 week after injection of dibutyrl-cAMP, the neurons were removed and grown on either MAG or myelin. At both times, the inhibition by MAG was completely reversed and growth on myelin was improved 6-fold. The improved growth was PKA dependent only at day 1, disappearing by 1 week presumably because of the early transient increase in cAMP."

    Current Pharmaceutical Design, 2005, 11, 1247-1253

    http://labs.pbrc.edu/bloodbrainbarri...DSCIKastin.pdf
    ______________

    CC archive

    Quote Originally Posted by Wise Young 12/09/2004
    Chris2, the unknown factor is dibutyrl cAMP (db cAMP). This is a very potent excitatory messenger that crosses indiscriminately across cell memberanes. Since cAMP is the universal messenger for a huge variety of cellular reactions, it is unclear what this material will do to the spinal cord. Let me give you some examples things that we need to consider.

    First, during the first week after injury, there are probably more macrophages at the injury site of the spinal cord than any other type of cell. It is possible that db cAMP is stimulating macrophages to secrete growth factors that in turn cause axons to grow, instead of (as Marie Filbin suggests) raising cAMP inside axons and causing them to ignore the growth inhibitors. Another possibility is that the db cAMP is stimulating astrocytes to secrete GDNF (after all, it is called glial-derived neurotrophic factor). A third possibility is that it is increasing the excitability of neurons. Please note that many therapies stimulate rises of cAMP in axons. These include catecholamines. In fact, when we measured cAMP in the spinal cord shortly after a contusion injury, we found very high levels of cAMP. This may very well be related to a massive release of catecholamines that has been documented to occur in acute spinal cord injury.

    Second, cAMP increases axonal growth. One of the questions that needs to be answered is whether or not it increases aberrant sprouting of sensory fibers and neuropathic pain. This is always an issue that needs to be considered when growth factors are placed on the spinal cord. By the way, neither Marie Filbin nor Pearce/Bunge have found that db cAMP does not enhance neuropathic pain behaviors in rats after spinal cord injury. Moreover, Minami, et al. (1997) had reported that db cAMP reduced nociceptin-induced allodynia.

    Third, cAMP regulates expression of variety of receptors on cells, including GABA A receptor on reactive astrocytes (Hosli, et al., 1997), neurokinin1 receptors in neonatal spinal neurons (Abrahams, et al., 1999).

    Fourth, db cAMP alone may not be sufficient to stimulate axonal growth. Marie Filbin has shown that conditioning lesions of peripheral nerve stimulates growth of the central branch of dorsal root ganglia and is associated with increased cAMP in dorsal root ganglion neurons. However, Han, et al. (2004) reported that injection of db cAMP alone into the dorsal root ganglion does not necessarily stimulate axonal growth.

    Fifth, certain by-products of membrane breakdown are more toxic to astrocytes when cAMP levels are elevated in the astrocytes (Bochelen, et al. 2000).

    There are countless other examples of dibutyrl cAMP effects on cells of the spinal cord. I am giving only a few example. So, there is a need to careful dose-response and safety studies of db cAMP administration into the spinal cord of humans.


    References Cited.(see link http://sci.rutgers.edu/forum/newrepl...reply&p=116669)

    Quote Originally Posted by Wise Young 12/11/2004
    Mike, it is not an easy task. To my knowledge, no dose-response data is available. Let me describe to you the kind of experiment that we would do if there were funds to do so.

    1. Small animal safety study. We would do a dose-escalation study with short-term outcomes first to look for tissue damage. This would probably require two separate experiments since tissue damage needs to be looked at several hours, several days, and several weeks after the injection of the db cAMP. The acute effects of the db cAMP wll need to be before.

    2. Small animal efficacy study. This probably needs to be done wth anesthesia and without anesthesia. Optimizing the cAMP for efficiacy is the more difficult study. It would require waiting for the animal to regenerate. This may take several weeks. Obviously, the toxicity study needs to be done first, to find the range of doses where the treatment does not acutely harm the spinal cord. The animals probably need to be kept for 6-12 weeks to see if they regenerate and regain function, compared against control untreated animals.

    3. Large animal safety study. Once the studies are completed in a small animal, a large animal study would be required. The FDA requries safety data from a large species and a small species (usually rodent). In the larger species, obviously, you want to minimize the number of animals used and you want to do it only once for long term followup purposes.

    I think that the small animal study will probably require 200 rats and 12 months to complete and about $200,000 of animals, supplies, and personnel to carry out. The large animal study may cost $100,000 and again 6-12 months to complete for both safety and efficacy indications.

    Wse.
    Last edited by chasb; 11-19-2007 at 03:29 AM.

  7. #217
    Quote Originally Posted by poonsuzanne
    Corinne,

    This is one of the ideas we should consider:-

    Maybe someone with a core group of volunteers should help Dr. Davies to set up a foundation which is specially dedicated to raise funds for his research work. What would you think?

    Suzanne

    ****************

    Oh, I am sorry I might be wrong!! Setting up a foundation is a lot of work and time consuming. But I am hoping to see that some people will lead in the fund raising efforts for Dr. Davies in a consistent and urgent manner.
    Suzanne,
    yes, why not a foundation ?
    Kate's simple idea of a 'virtuous chain' was also good, I think...
    but I don't see much positive feedback ... anybody else thinking that WE should join forces and act ?

  8. #218
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    Quote Originally Posted by Corinne Jeanmaire
    Suzanne,
    yes, why not a foundation ?
    Kate's simple idea of a 'virtuous chain' was also good, I think...
    but I don't see much positive feedback ... anybody else thinking that WE should join forces and act ?
    Many of us “believe we're on the safe side you know”--

  9. #219
    I plan to give a small amount ($20-$30) monthly to Dr. Davies research and to request that friends and family make donations to him in lieu of Christmas gifts to me. Although I would love to support Dr. Young in a similar way, I am drawn to Dr. Davies' research because he is doing it in the USA (thus easier to access once it is approved) and because he has a plan to involve chronics soon after doing trials with acutes.

  10. #220
    Quote Originally Posted by Corinne Jeanmaire
    Suzanne,
    yes, why not a foundation ?
    Kate's simple idea of a 'virtuous chain' was also good, I think...
    but I don't see much positive feedback ... anybody else thinking that WE should join forces and act ?
    Corinne,

    I belive we have already enough foundation we can use (they cost time and money), for example I was going to propose that here in europe we could collect our donations using Cherry charity (I did not ask her yet) and then she can forward the money to Prof. Davies. In that way we should save some transfer fees.. I personally belive it is realistic to collect 10000 Euros by Christmas! I can put 500€, who else take the challenge??



    P.S. Cherry if you see this, what do yiu think?
    Last edited by paolocipolla; 11-25-2007 at 08:42 PM.

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