Thread: ChinaSCINet Update

  1. #2031
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    Dr. Young,

    If everything goes well with the trial and it is approved. How are you and your team planning to dealing with the surge to get the therapy?

  2. #2032
    Dr. Wise,
    If the expanded use access of the therapy is approved by the FDA in the U.S. or the EMA in Europe, what about other countries such as China?Thank you.

  3. #2033
    tang,

    If you read Jim's earlier post, I think he mentioned the Chinese Ministry of Health - I think the trial will be to gain approval of them as well as the US.

    Dr Wise
    When this therapy has been approved, (hopefully,) does it exclude people such as myself, who have developed syringomyelia as a result of a traumatic injury? (such as burst fractures due to road traffic accidents or other traumatic situations.) I know that one of the trial participation exclusions are a large syringomyelia. I have one from T5 to C1/ very close to brain stem, and am now an ASIA B from being an ASIA A a year and a half ago. One of the consultants said they wouldn't touch with this therapy. So of course, I'm now very curious.

    We can't thank you and all those involved enough. And thanks Jim for your work in the forums, and out.


    Regards

  4. #2034
    Quote Originally Posted by taymas View Post
    tang,

    If you read Jim's earlier post, I think he mentioned the Chinese Ministry of Health - I think the trial will be to gain approval of them as well as the US.

    Dr Wise
    When this therapy has been approved, (hopefully,) does it exclude people such as myself, who have developed syringomyelia as a result of a traumatic injury? (such as burst fractures due to road traffic accidents or other traumatic situations.) I know that one of the trial participation exclusions are a large syringomyelia. I have one from T5 to C1/ very close to brain stem, and am now an ASIA B from being an ASIA A a year and a half ago. One of the consultants said they wouldn't touch with this therapy. So of course, I'm now very curious.

    We can't thank you and all those involved enough. And thanks Jim for your work in the forums, and out.


    Regards
    Taymas,

    Our trials did exclude those subjects who had large syringomyelic cysts that occupied more than a third of the width of the spinal cord. The reason was that we did not want to inject the cells into the cyst. If our trial shows that the umbilical cord blood mononuclear cells are effective for chronic complete spinal cord injury, one possibility is that doctors may first operate to untether your spinal cord and collapse the syringomyelic cyst, confirm that it is gone, and then transplant the cells into the spinal cord.

    Wise.

  5. #2035
    Quote Originally Posted by Wise Young View Post
    Taymas,

    Our trials did exclude those subjects who had large syringomyelic cysts that occupied more than a third of the width of the spinal cord. The reason was that we did not want to inject the cells into the cyst. If our trial shows that the umbilical cord blood mononuclear cells are effective for chronic complete spinal cord injury, one possibility is that doctors may first operate to untether your spinal cord and collapse the syringomyelic cyst, confirm that it is gone, and then transplant the cells into the spinal cord.

    Wise.
    Thank you Dr, I appreciate your reply

    I understand the requirement of untethering, but surgeons are keen on using a shunt once untethering is done. I would imagine the shunt would have to be removed prior to implantation of cells? Theoretically, would there be an issue implanting the cells UPON collapsing the syrinx in the SAME surgery? I'm just not convinced that my syrinx, extending up to C1/2 could ever be collapsed completely - maybe we have pessimistic surgeons here in the UK

    Regardless, stay strong Dr, I can't imagine the sheer load on you and your team; gathering gargantuan amounts of data, and trying to get published.

    Warmest regards.

  6. #2036
    This thread is so long and veers off course to some degree so it's had to tell if there is any early indication whether this procedure is effective or not. Simple question, is there any early indication?

  7. #2037
    Quote Originally Posted by Eric.S View Post
    This thread is so long and veers off course to some degree so it's had to tell if there is any early indication whether this procedure is effective or not. Simple question, is there any early indication?
    Hi Eric don't know if I'm going to be much help, but the gist I'm getting is they can't say yet until they publish their findings officially (every trial needs this I imagine) - this of course is in relation to Phase II. Whether or not it is "effective," they will have to confirm their findings in a Phase III trial. Of course it would have to be effective to go to Phase III in the first place, so it is mainly for confirmation and to gain regulatory approval. There was some mention if you see the last 10 pages, that we may be able to see this therapy AS the third phase commences, on grounds of "compassionate use", if it is proven to be safe and effective "what Phase I and II are about.

    Anyone feel free to correct me if I'm wrong.

    Regards

  8. #2038
    Quote Originally Posted by taymas View Post
    Hi Eric don't know if I'm going to be much help, but the gist I'm getting is they can't say yet until they publish their findings officially (every trial needs this I imagine) - this of course is in relation to Phase II. Whether or not it is "effective," they will have to confirm their findings in a Phase III trial. Of course it would have to be effective to go to Phase III in the first place, so it is mainly for confirmation and to gain regulatory approval. There was some mention if you see the last 10 pages, that we may be able to see this therapy AS the third phase commences, on grounds of "compassionate use", if it is proven to be safe and effective "what Phase I and II are about.

    Anyone feel free to correct me if I'm wrong.

    Regards

    which phase is the trial in currently? Even though its purpose is safety I would imagine there would be some early indication whether a trial works or not in the first phase.. if more than 1 person is seeing returns in functions i'd imagine thats from the procedure.

  9. #2039
    Quote Originally Posted by Eric.S View Post
    which phase is the trial in currently? Even though its purpose is safety I would imagine there would be some early indication whether a trial works or not in the first phase.. if more than 1 person is seeing returns in functions i'd imagine thats from the procedure.
    Hey Eric,
    I believe we are now awaiting the beginning of Phase III, which seems like it will be 2015.

    Now I don't know if I can answer the question on effectiveness, but I did read a press release which seemed positive on the ChinaSCINet site, (I think). We will have to await publication of the findings to be certain (of previous Phase). But my personal impression was that majority of participants had
    positive results. PM me and I'll see if I can find the link for you. As I am not affiliated with anyone here, I only speak as a fellow SCI. I know that there seems to bee TOO much ambiguity, but they can't be transparent or they jeopardise their findings/credibility (for whatever reason; ethics, false hope, I don't know only they can answer.) We will have to wait so they do things properly. I would love to hear an update, but if it is damaging to any process then I don't want to know.

    Regards.

  10. #2040
    Eric,

    I work with Dr. Young at Rutgers.

    The ChinaSCINet Phase II Trial has been completed. 15 of 20 subjects are able to walk long distances using upper body supporting rolling walkers. 2 of the 15 are able to walk with walkers. Most subjects had major increases in their Spinal Cord Independence Measure scores, mainly in the mobility/bowel/bladder categories.

    Phase III Trials are now being planned to take place next year in China, US, Norway and India.

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