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Thread: ChinaSCINet Update

  1. #411
    Quote Originally Posted by Imight View Post

    Anyways, what happened to the updates anyways? lol How are the patients in HK doing?
    no crap! what gives? isnt 1 year coming up for the 1st patient?

  2. #412
    Let me first describe CN102B HK. This is the trial in Hong Kong where we are transplanting increasing doses of umbilical cord blood mononuclear cells into the spinal cord. The first group of four received 1.8 million cells. It turned out to be safe and so the second group received 3.2 million cells. We have done three patient in this group and a patient is scheduled at the end of September. As soon as we do that patient and the treatment is safe, we will transplant 6.4 million cells into the next four patient. If that turns out to be safe, we will transplant 6.4 million plus a bolus dose of 30 mg/kg methylprednisolone at the time of transplantation. Finally, the fifth group of four patients will receive 6.4 million plus methylprednisolone and a 6-week course of lithium.

    The slow pace of patient recruitment in Hong Kong has been frustrating. We have not done any patients since April, despite very intense television and radio publicity for the trial. Our next patient is scheduled for the end of September. We are discussing the possibility of applying to the IRB for permission to do patients from China, where there are many more patients. We would have to raise some funds because Hong Kong residents are paid for but outside patients are not. I presented to the Board of HKSCIFund and they are willing to do so.

    In the meantime, Kunming is progressing. They are doing the same trails (CN102B Kunming). All 20 patients have already been recruited for Kunming. they have no shortage of patients but we want to make sure that they can process and monitor the cells accurately and rigorously. They have been tested on 3 units of cord blood. They need to pass one more test unit to do but I anticipate that they will start on the their first patients at the end of September and they will have done all 20 patients before Christmas.

    We have been waiting for the safety data from these two trials so that we can apply to the U.S. FDA for a phase 3 trial and the European Medicines Agency (EMA) to do the trial in Norway. On October 29 to November 4, we are hosting a team of 9 Norwegian doctors and trial organizers in Hong Kong and Kunming. We are hoping that they will be able to see the surgery and the intensive rehabilitation that they do in Kunming.

    Wise.

  3. #413
    dear Wise,it is great plan!

  4. #414
    Senior Member
    Join Date
    Jun 2011
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    North Carolina
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    Dr. Wise just out of curiosity if all goes as planed when will you start the trials in the US.

  5. #415

  6. #416
    sounds like you need me to get a the first plane out to hong kong!

    so basically, you cant even apply to the FDA for the phase 3 until a year after the last patient in HK and Kunming?
    how many patients can be included in a phase 3 trial?

  7. #417
    Quote Originally Posted by #LHB# View Post
    Dr. Wise just out of curiosity if all goes as planed when will you start the trials in the US.
    Beginning of 2012

  8. #418
    Quote Originally Posted by Jim View Post
    Beginning of 2012
    does that mean thats when recruitment will start?

  9. #419
    Quote Originally Posted by Barrington314mx View Post
    sounds like you need me to get a the first plane out to hong kong!

    so basically, you cant even apply to the FDA for the phase 3 until a year after the last patient in HK and Kunming?
    how many patients can be included in a phase 3 trial?
    Barrington,

    The phase 3 trials of course must come after the phase 2. We are planning phase 3 trials in China (n=400), US (n=120), Norway (n=60), and possibly India (n=60) in 2012. Exactly when depends on the progress of the phase 2 trails now underway.

    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.

    By the way, Jim is referring to a planned phase 2 trial that we hope to start in Austin (TX) in Q2 of 2012, to assess the feasibility of doing the surgery and intensive locomotor training in the United States.

    Wise.

  10. #420
    Wise, how would one go about encouraging Canadian surgeons to come and observe too?

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