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Thread: Comment on the SCINetUSA phase I/II and III trials

  1. #51
    Quote Originally Posted by lockedinself View Post
    what is the exact approch for scar formation at the injury site in this clinical trial ?
    lockedinself,

    I am sorry that I did not see your comment earlier. The cells are being injected into the spinal cord above and below in the injury site. In animal studies, we have seen that the cells migrate from the injections sites into the injury site, providing a bridge across the injury site.

    In my opinion, most people do not form a "fibrous scar" at their injury sites unless they had an injury that is caused a penetrating wound at the injury site and exposed the injury site to outside tissues. Yes, glial cells do proliferate at the injury edge but these do not form "scar" in the traditional sense.

    Glial cells can wall off the injury site if the damage is severe. The job of glial cells is to separate the central nervous system from peripheral tissues. They form the blood brain barrier, the PNS/CNS (peripheral nervous system/central nervous system) barriers, and the CNS/Arachnoid barrier.

    Gliosis (an accumulation of glial cells) can provide a barrier to axonal growth. If one tries to remove glia surgically, this will only cause more gliosis. The only way to handle this barrier is to build a cellular bridge through the barrier. That is what we are doing by transplanting umbilical cord blood mononuclear cells (UCBMC) into the surrounding cord.

    UCBMC are attractive as a cell bridge across the injury site for several reasons. First, they do not evoke a glial reaction. In other words, the cells are not recognized by glial cells are being extra-CNS and the astrocytes do not proliferate and try to wall off these cells, in contrast to fibroblasts and Schwann cells, which can induce gliosis. Second, UCBMC do not transform into a variety of different cells after transplantation into the spinal cord. They migrate into the injury site and form a continuous bridge. Third, the cells can be HLA-matched (so that they are not or less likely to be immune rejected) and should survive at the injury site long enough to support axonal growth across the injury site.

    I know that a lot of people are thinking that we are transplanting umbilical cord blood stem cells into the spinal cord. Indeed UCBMC do include some stem cells. However, we don't see the cells producing many other kinds of cells in the spinal cord. At least over the period of several months after the transplantation, we don't see the cells becoming oligodendroglia, astrocytes, or neurons. They continue to look like mononuclear cells. However, we have found that the cells secrete neurotrophins, particularly when stimulated with lithium. That is why the trial will compare neurological recovery in transplanted patients treated with lithium or no lithium.

    Wise.

  2. #52
    Thank you Wise for the explanation of your testing. Hopefully the outcome will be the one in ten that is positive. Hopefully you can translatew your results to chronic non traumatic cases like transverse myelits.

    Tony J

  3. #53
    Good onya Wise! All sounds good to me. Perhaps someone could saddle up next to young Billy Gates and wisper in his ear. Surely, $40 million would only be parking meter money for him. I'm well aware of the good work his foundation is doing for Melaria research and well all hope that is sucessfull but by hell, it could only take a fraction of what he is putting into that to make a big shift in this area of human suffering!!

  4. #54
    so the USA trial is set to begin in 2012, from what ive found. does this mean that is when they will start recruiting? or will this be the beginning of the 6 month "prescreening" that the selected patients will go through?

    if everything goes as planned, and this trial shows effectiveness, will this go straight to FDA approval for therapy, or will there be another larger trail required?

    since the hong kong trial is going to be quite a bit ahead of the US trial, is it possible that a therapy could go public in china before the US, and/or does that affect the US trial in any way?

    in regards to patients that undergo this trial... from my understanding some patients are getting larger doses of cells and lithium than others. if its found that the patients need the larger dose, how does this effect someone who has had the smaller dose?

  5. #55
    Barrington,

    Check this out, and pm me your email, I'll add you to our eBulliten list.

    eBulletin

  6. #56
    thanks jim. PM sent.

  7. #57
    Quote Originally Posted by Barrington314mx View Post
    if everything goes as planned, and this trial shows effectiveness, will this go straight to FDA approval for therapy, or will there be another larger trail required?

    since the hong kong trial is going to be quite a bit ahead of the US trial, is it possible that a therapy could go public in china before the US, and/or does that affect the US trial in any way?
    These are the two questions i'd like to get an answer too.

  8. #58
    Quote Originally Posted by Barrington314mx View Post
    so the USA trial is set to begin in 2012, from what ive found. does this mean that is when they will start recruiting? or will this be the beginning of the 6 month "prescreening" that the selected patients will go through?

    if everything goes as planned, and this trial shows effectiveness, will this go straight to FDA approval for therapy, or will there be another larger trail required?

    since the hong kong trial is going to be quite a bit ahead of the US trial, is it possible that a therapy could go public in china before the US, and/or does that affect the US trial in any way?

    in regards to patients that undergo this trial... from my understanding some patients are getting larger doses of cells and lithium than others. if its found that the patients need the larger dose, how does this effect someone who has had the smaller dose?
    still looking for most of these answers if anyone can touch on them at all. thanks.

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