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Thread: ChinaSCINet Update

  1. #441
    has recruitment already started for the US phase 2 in austin, tx? im sure there will be no shortage of patients for it, im just wonder about time to go through all those apps.
    especially when you move to 400 in phase3. thats gotta take some serious time to review all those people.

  2. #442
    Barrington, recruitment hasn't started yet but when it does we will let you know.

    400 patients won't be that bad when divided by 8 - 10 centers.

  3. #443
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    Good news that trials have started in china.

    Is it possible for you Dr Wise to include lower injuries in trials? May be they can also get function back who knows.

  4. #444
    Senior Member 0xSquidy's Avatar
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    Quote Originally Posted by Jawaid View Post
    Good news that trials have started in china.

    Is it possible for you Dr Wise to include lower injuries in trials? May be they can also get function back who knows.
    Trials in china started months ago. And how many times will you ask Wise to include your injury in the trial? He answered specifically to you like a milion times.

    Take it easy dude, just asking is not gonna cure you faster.
    Don't ask what clinical trials can do for you, ask what you can do for clinical trials.

    Fenexy: Proyecto Volver a Caminar

    http://www.fenexy.org (soon in english too)

  5. #445
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    Ox u r right my dear. I am sorry but bit frusteration u know.

    May be Dr Wise can expand trials criteria later to include lower injuries that is why asking.

  6. #446
    im pretty sure he has explained why they cant take higher or lower injuries, and have also stated that at a later date they would try to include them and older and younger patients. im sure its in this 45 page thread somewhere.

  7. #447
    Does anyone know how many patients have had the procedure?

  8. #448
    Quote Originally Posted by Mrs770 View Post
    Does anyone know how many patients have had the procedure?
    approximately 8 or 9 in hong kong so far and 2 in kunming.

  9. #449
    Senior Member Imight's Avatar
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    Quote Originally Posted by Wise Young View Post
    Tetracyclone,

    We are still working on the phase 3 design. At the present, in CN103 (the ChinaSCINet trial), we are planning to transplant umbilical cord blood mononuclear cells (UCBMC) into 400 subjects and randomize two groups of subjects with ASIA Impairment Scale (AIS) A, B, or C chronic spinal cord injury to a 6 week course of placebo or lithium. The latter will be "blinded" or "masked" so that neither the doctors nor patients know whether the patient is getting placebo of lithium.

    The problem, as you point out, is how to deal with and assess the role of rehabilitation. We encourage every participating center to provide intensive locomotor training. That is not possible, however. So, we are planning to do three things to ascertain whether the walking training is important:

    1. In the trials, we will monitor intensity of locomotor training with a daily diary by the patient
    (emailed daily by the patient to the testing center) and also a pedometer (or other device to measure hip movement).
    2. In the upcoming U.S. phase 2 trial (US102 in Austin), we are planning to randomize patients to standard rehabilitation and a more intensive walking program after treatment.
    3. In the upcoming ChinaSCINet Phase 3 trial (CN103), we will randomize subjects to intensive or standard locomotor rehabilitation. To do the latter, the subjects will go to Kunming.

    We are hoping to get US102 started in Austin (TX) early in 2012, to assess how feasible it would be to do 6 hours a day for 5 days a week training.

    Wise.
    Awesome! now this is what I like to read. promising news. Can't wait!

  10. #450
    Quote Originally Posted by Barrington314mx View Post
    approximately 8 or 9 in hong kong so far and 2 in kunming.
    Another two received cells in Kunming for a total of 4 chronic patients in Kunming. Wise.

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