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Thread: Stephen Davies Update

  1. #201
    Hi Suzanne,
    Sorry for the delay in getting back on the forum. I have been at the Society for Neurosciences meeting in San Diego this past week. So here are answers to your questions in bold type after each question.

    [quote=poonsuzanne]Hi, Dr. Davies,

    I am very much interested in your groundbreaking work. They are absolutely exciting news with lots of potential to all SCIs concerned!!

    Please allow me to have the following questions:-

    1. As Schmeky said:-

    a. Rat GDA BMPs have proven to evoke robust recovery in the acutely injured adult rat CNS; &
    b. Production of a scalable, purified human GDA BMP

    Should I assume that, in the meantime, GDA BMP will also be applied to chronic cords on rats?

    Answer: Yes. Given the robust and multiple benefits of GDA BMPs for acute SCI, we will be testing the effects of these cells in chronic SCI rats in the next few months. As mentioned by Schmeky we are also working hard to develop human GDA BMP cells and their GMP production. These human cells will also of course be tested both in acute and chronic SCI rats.

    2. In one of your answers to CC member here on the question of Decorin, you said, “We are now applying what we have learned with transection injuries and working on contusion injuries with several collaborating labs.” I have two questions here:-

    i. Will you work on the contusion models in both acute and chronic at the same time?
    ii. Will you be doing the same as stated above by using Rat GDA BMP?

    Answer: We have set up a collaboration with the Miami Project (at their request) to test rat GDA BMP cells in rat contusion injuries, at the Miami Project. Initial experiments will be conducted in acute contusion SCI rats to verify our acute SCI results. The first experiments testing rat GDA BMPs and chronic SCI injured rats will be conducted in my lab here in Colorado with transection injuries. As my lab also has a rat SCI contusion device, we may also first test GDA BMP cells in chronic contusion SCI rats before collaborating with other labs on these chronic experiments. We have also set up GDA related collaborations with other top labs that have experience with measuring recovery of bladder, bowel and sexual function in contusion SCI in rats.

    3. In your answer, you also said, “Do the basic science in a transection injury where you can actually measure how efficiently you have changed levels of inhibitors or other aspects of scar formation and then, apply what you have learned to contusion injuries where the only outcome measures are usually whether there was functional recovery and/or sparing of neuron cell bodies and myelin/support cells, and it is therefore difficult to work out mechanisms.”

    I am sorry do you mean that one would be unable or difficult to measure the change of levels of inhibitors or other aspects of scar formation in contusion injuries?

    Answer: Yes you are correct. Even when using computer controlled contusion devices it is well known that there is still enough variation between the size of injuries and post traumatic inflammation from animal to animal to make quantification of injury associated molecules e.g. CSPGs very difficult. Molecules like CSPGs come in different isoforms or subtypes (often different molecular weights) that can have very different effects on SCI recovery when present or absent, or even when in different ratios. We have found that transection injuries have far less variation and allow us to conduct proper quantitative molecular analysis of changes in spinal cord scar formation and efficiency of axon regeneration when using new treatments such as GDAs and decorin. We are now set to apply what we have already learned with transection injuries to both acute and chronic contusion injuries. If we want to develop truly effective new therapies for SCI clinical trials that also avoid nasty side effects like pain then we need to understand the molecular mechanisms of their action as mush as possible in rats before testing them on people.

    4. Shall I assume that the combo therapy of Decorin + GDA BMP can be applied on humans in 2 to 3 years’ time or should it be in the time frame of 2 to 5 years?

    Answer: Yes, given sufficient funding we are shooting for the 2-3 year time frame rather than the 2-5 year. As Schmeky mentioned in his report, he met with Dr. Kevin Lillehei, a world renowned neurosurgeon who has already committed to designing and conducting SCI clinical trials here in Denver.

    5. Would it be possible for you to kindly outline your work and the gap of expenses that you require in your lab in the coming years of 2008 and/or 2009 so that Schmeky and other members can better plan our own individual donation schemes to your lab with all of the promising work going on?

    Answer: I am happy for you to contact me directly by email at Stephen.Davies@UCHSC.edu and I can provide you with more details of our plans and projected funding requirements to move to SCI clinical trials here in the USA with human decorin and human GDAs. Schmeky knows my lab has a lot more data and collaborations with biotech companies that I am not prepared to talk about on a public forum at this time.

    I hope this post answers some of your questions and those raised by other CC forum members that are interested in supporting our SCI research here in Denver.

    Stephen Davies.

  2. #202
    Senior Member poonsuzanne's Avatar
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    Dr. Davies,

    Thank you so much for sparing your valuable time to give us detailed and responsible answers to some of our concerns of your work!!

    First of all, I would like to whole-heartily thank you for being a scientist who works in the area of SCI. Moreover, we feel extremely lucky to have SCI scientists like yourself who have been fighting so hard for decades (I am not sure the number of years of your involvement) to try to reverse our destiny.

    You have definitely answered more than I have asked. I will, therefore, definitely draw up a donation plan with my family ASAP and, in the meantime, I will email you.

    Thanks again and again!!!

    Suzanne

    P.S. Please don't worry we all know you are always busy!
    Last edited by poonsuzanne; 11-11-2007 at 05:46 PM.
    Suzanne

  3. #203
    Senior Member poonsuzanne's Avatar
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    Dr. Davies,

    As an amateur fundraiser, from my perspective, may I conclude your research work in simple terms as follows:-

    In approximately two years, given adequate funding support: -

    1. The research work of Decorin and GDA BMP will be completed in chronic transaction injuries and acute and chronic contusion injuries, with the understanding that acute transaction studies on both have already been done with promising results; &

    2. In the meantime, all of the above work will also be replicated in other labs before application on humans.

    Therefore, clinical trials on the combo therapy of Decorin and GDA BMP can be expected to arrive in 2-3 years.

    Suzanne
    Last edited by poonsuzanne; 11-11-2007 at 07:26 PM.
    Suzanne

  4. #204
    Quote Originally Posted by poonsuzanne
    Dr. Davies,

    As an amateur fundraiser, from my perspective, may I conclude your research work in simple terms as follows:-

    In approximately two years, given adequate funding support: -

    1. The research work of Decorin and GDA BMP will be completed in chronic transaction injuries and acute and chronic contusion injuries, with the understanding that acute transaction studies on both have already been done with promising results; &

    2. In the meantime, all of the above work will also be replicated in other labs before application on humans.

    Therefore, clinical trials on the combo therapy of Decorin and GDA BMP can be expected to arrive in 2-3 years.

    Suzanne
    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.

  5. #205
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    Wink

    Dr. Davies,
    We have concerns for your safety. Perhaps you would like to enjoy hazard free past times for several years....

    Thank you for your efforts - the check is in the mail!

  6. #206
    Quote Originally Posted by The mom
    Dr. Davies,
    We have concerns for your safety. Perhaps you would like to enjoy hazard free past times for several years....

    Thank you for your efforts - the check is in the mail!
    Ditto!

  7. #207
    Quote Originally Posted by The mom
    Dr. Davies,
    We have concerns for your safety. Perhaps you would like to enjoy hazard free past times for several years....

    Thank you for your efforts - the check is in the mail!
    Thanks for your support of our work. You will be pleased to hear I recently sold the sportbike and the race car. Given the amount of time I spend either in the lab or with my son Max, I don't have much time left for dangerous sports anymore!

  8. #208
    Senior Member Kratos's Avatar
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    lol doc, if you cure us i will buy you a new bike

  9. #209
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    Dr. Davies:

    Thank you very much for your cutting-edge research on SCI cure. As someone with chronic quadriplegia from SCI for the last five years, I cannot begin to tell you how hopeful and excited I feel reading your and Schemeky's posts. I intend to do what I can to raise funds for your research from my friends and family.

    I have a few questions. I would appreciate it very much if you could find time to respond to them.
    1. Schemeky's last report from Texas, I think, mentioned that you were aiming to have even more robust regeneration of axons across the injury site than the results obtained at the time in acute transection injuries with GDA BMP. Have you had any success with that yet?
    2. If I understand right, introducing GDA BMP at the injury site helps grow axons. What strategy would you recommend applying/researching to deal with loss of neurons at the injury site where necessary?
    3. What is the source of the human GDA BMP you are working with? I personally believe that it is not only moral but it is morally imperative to use ethically donated human embryonic stem cells for research, treatment, and cure of catastrophic medical conditions and injuries like the spinal cord injury. I know it is likely that some people I approach for donations would ask about the source of the human GDA BMP you are working with. I would like to be able to answer their questions. On these lines I would like to know your comments about the possibility of using the Gladstone Institute's Dr. Shinya Yamanaka's ongoing research on creating human pluripotent embryonic stem cell like cells from skin cells in the future.
    4. You had mentioned a few times about waiting to disclose complete results/research until the study is published in a journal. I understand it takes time for the articles to be published. Would this in any way delay other studies/the clinical trial timeline?
    5. Finally here is my summarization of different studies I understand you have planned for. Could you please fill in the blanks based on your best estimate assuming you have all the necessary resources available, and correct them as per your plans. I understand this would be the most optimistic scenario, and must be understood as such. It will be very useful nevertheless. And of course, FDA trials will not need replication in the same way as laboratory rat studies. Please comment.
    Thank you.
    Last edited by Quad62; 11-15-2007 at 01:29 AM. Reason: Clean up of attachment

  10. #210
    [quote=Quad62]Dr. Davies:

    Thank you very much for your cutting-edge research on SCI cure. As someone with chronic quadriplegia from SCI for the last five years, I cannot begin to tell you how hopeful and excited I feel reading your and Schemeky's posts. I intend to do what I can to raise funds for your research from my friends and family.

    I have a few questions. I would appreciate it very much if you could find time to respond to them.
    1. Schemeky's last report from Texas, I think, mentioned that you were aiming to have even more robust regeneration of axons across the injury site than the results obtained at the time in acute transection injuries with GDA BMP. Have you had any success with that yet?
    Answer: Experiments are underway. The 40% efficiency in just 8 days that we have already achieved is still way better than has been demonstrated for any other cell type.
    Note that our data also indicates that transplanting undifferentiated neural stem or precursor cells (this would apply to stem cells from any source) into acute transection injuries does not promote axon growth or functional recovery in Gridwalk tests. Recent publications are showing that the Gridwalk test is far more stringent than the BBB test i.e. there can be improved BBB scores for a treatment that show no recovery at all in Gridwalk tests of SCI rats. In my opinion it is BBB scoring that accounts for many claims of recovery with stemcell treatments alone.
    1. If I understand right, introducing GDA BMP at the injury site helps grow axons. What strategy would you recommend applying/researching to deal with loss of neurons at the injury site where necessary?
    Answer: Neuroprotection at acute stages will help prevent neuron loss. In my opinion the hypothermia treatment looks very promising. Researchers are realizing that the clinical trails for this treatment a few years back in the US were not conducted properly i.e. too many variables. For chronic injury then a neuron replacement / stemcell strategy would be needed if there is extensive neuron loss, particularly of motor neurons in the cervical or lumbar enlargements of the cord.
    1. What is the source of the human GDA BMP you are working with? I personally believe that it is not only moral but it is morally imperative to use ethically donated human embryonic stem cells for research, treatment, and cure of catastrophic medical conditions and injuries like the spinal cord injury. I know it is likely that some people I approach for donations would ask about the source of the human GDA BMP you are working with. I would like to be able to answer their questions. On these lines I would like to know your comments about the possibility of using the Gladstone Institute's Dr. Shinya Yamanaka's ongoing research on creating human pluripotent embryonic stem cell like cells from skin cells in the future.
    Answer: This is not information I am prepared to talk about in detail on a public forum, nor is it necessary for me to do so. Suffice to say we are exploring all federally approved stem cell options for making GDA BMPs. If adult stem cells are able to make GDA BMPs so much the better.
    1. You had mentioned a few times about waiting to disclose complete results/research until the study is published in a journal. I understand it takes time for the articles to be published. Would this in any way delay other studies/the clinical trial timeline?
    Answer: Short answer is that it does not delay our studies. Discussions with the FDA will determine how much data needs to be peer reviewed for approval to go to trial.


    Finally here is my summarization of different studies I understand you have planned for. Could you please fill in the blanks based on your best estimate assuming you have all the necessary resources available, and correct them as per your plans. I understand this would be the most optimistic scenario, and must be understood as such. It will be very useful nevertheless. And of course, FDA trials will not need replication in the same way as laboratory rat studies. Please comment.

    Answer: I can fully understand why you would like to be give clear dates at to when results are going to be obtained and trials are going to start. Unfortunately science does not work like this (nor does real life). If I gave some dates, there are those on the forum who would quite rightly loose all respect for me as an honest scientist. I have already made it quite clear about what experiments need to be done, and given positive data and sufficient funding, the earliest we esitmate we could be ready for clinical trials. What we are trying to accomplish is a lot more difficult that remyelinating spared axons after SCI, however the potential gains are much greater.


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