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Thread: ChinaSCINet Update

  1. #431
    sure does - but I don't think that has happened yet

  2. #432
    Quote Originally Posted by Wise Young View Post
    The phase 2 trials are going on now. If the trials indicate the treatment is safe and shows an impressive trend for improvement, we may apply for the phase 3 as early as March 2012 in hopes of an approval by July 2012. On the other hand, if we encounter problems, it may take longer.

    Wise.
    Who said anything about tremendous improvement? An impressive trend is one that is more than statistically significant. The fact that a safety dose of cells without mp or lithium has shown any return is pretty impressive on its own. Also, the fact that Wise is already planning to allocate resources to phase 3 trials is also encouraging. Wise is not going to share unpublished information in advance of the trial's completion. Speculating and trying to read into everything Wise posts is just going to make you more anxious.

  3. #433
    Quote Originally Posted by Christopher Paddon View Post
    sure does - but I don't think that has happened yet
    http://www.icontact-archive.com/9xHN...a8hh8Qtp_D?w=3
    "Seven patients already have been treated with no significant problems. Some have reported increased sensation and some recovery of function. However, results need to wait for the six-month independent examinations."



  4. #434
    Quote Originally Posted by KofQ View Post
    Who said anything about tremendous improvement? An impressive trend is one that is more than statistically significant. The fact that a safety dose of cells without mp or lithium has shown any return is pretty impressive on its own. Also, the fact that Wise is already planning to allocate resources to phase 3 trials is also encouraging. Wise is not going to share unpublished information in advance of the trial's completion. Speculating and trying to read into everything Wise posts is just going to make you more anxious.
    lunasic422 put in the word tremendous instead of impressive and I and others quoted it by mistake

  5. #435
    Quote Originally Posted by Christopher Paddon View Post
    lunasic422 put in the word tremendous instead of impressive and I and others quoted it by mistake
    I know. My point was that these trials are really just getting going and
    Wise would not be following proper protocol if he said too much. We have to wait for results, and waiting sucks, but trying to dissect everything that Wise says or writes will just stress you out even worse.

  6. #436
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    Quote Originally Posted by Isildur View Post
    No, they are now focusing in saving the planet and stuff like that
    Saving the planet is also important Isildur , but back to SCI therapies; from over here several chief physicians from our SCI-units, chief neurosurgeons from our National Hospital (Rikshospitalet), professors in basic science and in neuroscience and I and another fellow in a wheelchair will go. We are very much looking forward to this.

  7. #437
    Senior Member lunasicc42's Avatar
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    yeah sorry for that. I got ahead of myself
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  8. #438
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    Quote Originally Posted by lunasicc42 View Post
    yeah sorry for that. I got ahead of myself
    Ok, good or bad -we are going (to many places), but if you are negative we call it off. No problems.

  9. #439
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    Forgive me if this question has been answered. Is there a part of the phase 3 design that allows you to compare a group of SCId individuals receiving the cells and lithium and intensive therapy with another group that is getting the treatments but no PT? or would you just compare to a group getting only intensive PT? The second may be more ethical.

  10. #440
    Quote Originally Posted by Tetracyclone View Post
    Forgive me if this question has been answered. Is there a part of the phase 3 design that allows you to compare a group of SCId individuals receiving the cells and lithium and intensive therapy with another group that is getting the treatments but no PT? or would you just compare to a group getting only intensive PT? The second may be more ethical.
    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.

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