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Thread: Clinical Trials

  1. #311
    Quote Originally Posted by Wise Young View Post
    Scaper1, we will be injecting cells into the spinal cord above and below the injury site. People who have a C4 level would require injection of the cells into the C3 or C4 segment. The phrenic nerve is in that part of the spinal cord and injections of cells into this part of the spinal cord may compromise respiration.

    We are planning a trial for high quads (C1-C4) if the current trials show beneficial effects but modify the procedure so that the cells are injected into the injury site and on the caudal edge of the injury site. I think that this would be safer.

    Wise.
    would you accept a c4c5 incomplete walking quad?

  2. #312
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    Smile Hey Dr Wise

    Just wondering are there any trials coming to Australia or New Zealand, details would be greatly appreciated on behalf of a c3/c4 quad... ; )
    How does a blade of grass thank the sun?

  3. #313
    Senior Member mcferguson's Avatar
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    Quote Originally Posted by Wise Young View Post
    Mcferguson, I of course cannot speak for clinical trials that other investigators are carrying out and whether or not they will exclude subjects that have participated in other clinical trials. Participation in our clinical trial may preclude you from other clinical trials. However, I can speak for myself and the trials that I organize. SCINetUSA will be committed to the following principles for people who have already participated in our trials.

    1. If a trial shows that one therapeutic arm is effective and the other arms are not, we will do our very best to ensure that people who were randomized to non-effective arms of a trial will receive the effective treatment.

    2. We will design and plan clinical trials for those people who have participated in our clinical trial. A therapy may not be the cure for everybody and people are likely to need further therapy.

    3. We will tell people who ask what therapy they have received when the trials are over, if the therapy was masked (i.e. double-blind).

    Wise.
    Thanks. That's good to know. I'll be saving up my vacation and sick time.

  4. #314
    Quote Originally Posted by DA View Post
    what do you hope to accomplish?
    In the CN102B phase 2 trial being conducted in Hong Kong now, we are randomizing patients to five treatment groups, receiving 1.6, 3.2, or 6.4 million umbilical cord blood mononuclear cells (UCBMC), the highest "safe" dose of cells plus a bolus dose of methylprednisolone which improves survival of the cells, and that dose plus methylprednisolone and a 6-week course of lithium which we expect to cause the transplanted cells to proliferate in the spinal cord. If our hypothesis is correct, the escalating doses should not only be safe but should be associated with increasing function improvements in the patients. If so, we will proceed to CN103 in China, which will randomize 400 patients transplanted with UCBMC to a 6-week course of placebo or lithium.

    Depending on the results of the CN102B, we may proceed with US102A, which would be carried out in the Brackenridge Hospital in Austin, TX. This trial would assess the feasibility of doing the procedure in the U.S. This would be followed by US103, the phase 3 trial to establish efficacy,

    Wise

  5. #315
    Wise, sounds good to me. We're counting on ya.

  6. #316
    Senior Member DA's Avatar
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    Quote Originally Posted by Wise Young View Post
    In the CN102B phase 2 trial being conducted in Hong Kong now, we are randomizing patients to five treatment groups, receiving 1.6, 3.2, or 6.4 million umbilical cord blood mononuclear cells (UCBMC), the highest "safe" dose of cells plus a bolus dose of methylprednisolone which improves survival of the cells, and that dose plus methylprednisolone and a 6-week course of lithium which we expect to cause the transplanted cells to proliferate in the spinal cord. If our hypothesis is correct, the escalating doses should not only be safe but should be associated with increasing function improvements in the patients. If so, we will proceed to CN103 in China, which will randomize 400 patients transplanted with UCBMC to a 6-week course of placebo or lithium.

    Depending on the results of the CN102B, we may proceed with US102A, which would be carried out in the Brackenridge Hospital in Austin, TX. This trial would assess the feasibility of doing the procedure in the U.S. This would be followed by US103, the phase 3 trial to establish efficacy,

    Wise
    how much functional improvement are you thinking is possible?
    you told me you didnt know in austin, but c'mon, right or wrong you have to have an idea of what you think can happen.

  7. #317
    DA, Imust say that my recall of Wise expects is:

    1. restoration of bowel and bladder control
    2. REstoration of sexual function
    3. Restoration of balance
    4. Restoration fo walking

    These are what I got from previous posts; all the talk of going from 1 to 3 are not as improtant as functional restoration in real terms.

  8. #318
    Thanks for all the information! I will continue my efforts of raising some funds. We just need to get those China trials started. I'm surprised they are having difficulties rounding up some volunteers...I guess that just buys me some time to do my thing.

    Peace.

  9. #319
    Senior Member DA's Avatar
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    Quote Originally Posted by keeping on View Post
    DA, Imust say that my recall of Wise expects is:

    1. restoration of bowel and bladder control
    2. REstoration of sexual function
    3. Restoration of balance
    4. Restoration fo walking

    These are what I got from previous posts; all the talk of going from 1 to 3 are not as improtant as functional restoration in real terms.
    he also said the trial doesn't address every problem needed for cord regeneration so
    i dont understand how that is possible in a complete injury. he said it on the forum and he said it in person.

    my understanding of the trial is once complete, another therapy will be added. then start over with clinical trials. once complete, then add another therapy, then start trials all over again. once complete, then add the final therapy, start trials again.

  10. #320
    Quote Originally Posted by keeping on View Post
    DA, Imust say that my recall of Wise expects is:

    1. restoration of bowel and bladder control
    2. REstoration of sexual function
    3. Restoration of balance
    4. Restoration fo walking

    These are what I got from previous posts; all the talk of going from 1 to 3 are not as improtant as functional restoration in real terms.
    What else is left , my dear friend ? Lol

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