Thread: ChinaSCINet Update

  1. #991
    Quote Originally Posted by Jim View Post
    John, the data from the Phase 2 trial in Hong Kong/China will be available in November. This data is necessary for approval from the U.S. FDA to begin trials here. Recruitment won't be until 2013.
    Ok great, thanks. I saw Wise mention looking for recruits for the 2014 trial and thought recruitment for this one had begun

  2. #992
    wasnt it understood that the data would be necessary for trials in the US from the beginning? and that the data wouldnt be available until novemeber? but yet it was stated over and over that trials would begin in 2012? even recently (within a month or 2 ago)

  3. #993
    Barrington, the US Trials were projected to start in '12. There have been delays. Here's what Dr. Young posted a few months ago-


    A major part of the delay resulted from the Chinese Ministry of Health putting the first of their freezes on cell transplant trials in 2009. This forced us to change our plans to do the trial in Kunming and start it instead in Hong Kong. We lost over a year because of this delay and we started the trial in Hong Kong in the Fall of 2010.

    From October 2010 to October 2011, our teams in Hong Kong could only recruit 8 subjects that met the eligibility criteria. In the meantime, China gave permission and we started the trials in Kunming for the trial in Fall of 2011. Kunming just did their 20th patient. We have decided to close recruitment for both trials.

    I had hoped that we would have completed CN102B by Fall 2011 and that we could have started the phase 3 trials in 2012. We need the 6-month follow up data from CN102B to apply for the clinical trials in the U.S. and Europe. This data will be available 6 months from now.

    There is much to do in the meantime. We must raise the funds for the trials in China, U.S., and Europe. In China, we are working with investigators to apply for grants in China. In the U.S., we are raising funds through JustADollarPlease, Boyd Melson's boxing, Lone Star, and other approaches. In Europe, we are hoping to raise the money from the government of Norway.

    I am coming to India in September and hope to talk to investigators in to see if we can get the trials moving in India. As you know, the Apollo Hospital would like to go ahead and several other centers are interested. Again, funding is an unresolved issue. To tell you the truth, lack of funding is the major issue. If we had the funds, we would simply pay for the trials.

    But the news is otherwise good. So far, the therapy appears to be safe. Our surgeons feel comfortable with the procedure and believe that it is feasible. None of the subjects have lost significant function and some have gotten some function back. It is still too early to know how significant the improvements are but I believe that it is sufficient to justify going ahead with a phase 3 trial in China, U.S., Europe, and India.

    The symposium in Xi'an was really quite exciting. We now have several promising candidate therapies and viable sources of these therapies.

    Wise

  4. #994
    Quote Originally Posted by JohnMarz View Post
    Has recruitment begun for the umcb+lithium trial in the US?
    JohnMarz,

    We are not looking for "people candidates". We are looking for "therapy candidates" that we can put into trial in 2014.

    Wise.

  5. #995
    Quote Originally Posted by Barrington314mx View Post
    wasnt it understood that the data would be necessary for trials in the US from the beginning? and that the data wouldnt be available until novemeber? but yet it was stated over and over that trials would begin in 2012? even recently (within a month or 2 ago)
    The Phase III trial is planned to start mid-2013 in the United States and China, assuming that we get the clinical trials approved by the regulatory authorities. We were hoping that we could get the safety data to allow us to get the Phase II trial in Brackenridge Hospital in Austin started in 2012. However, it is beginning to look as if this is not possible. I recently learned the Brackenridge Hospital just lost their rehabilitation doctor who was going to be the investigator of our trial there and we are still struggling to raise the funds for the trial. I am not sure that we will be able to identify a new investigator and get the regulatory approval for a phase II trial in Austin within 2012. We are considering all the options right now, including starting a phase II trial in New Jersey instead.

    Wise.

  6. #996
    thanks for the replys. hope all the pieces begin to fall in place.

  7. #997
    Senior Member okwjoe's Avatar
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    Dr. Young.. Phase 2 at kessler? Would a C4-5 Asaia A 22 yo man be elgible? We live in Fort Lee

  8. #998
    Quote Originally Posted by okwjoe View Post
    Dr. Young.. Phase 2 at kessler? Would a C4-5 Asaia A 22 yo man be elgible? We live in Fort Lee
    Hi. I have started posting things relevant to SCINetUSA in its own topic http://sci.rutgers.edu/forum/showthread.php?t=117784.

    Wise.

  9. #999
    Regarding ChinaSCINet, several things have been going on in the past month:

    1. We have had several meetings now with the senior leadership of the Ministry of Health in China. They have given us some good and frank advice that we are now scrambling to implement, including setting up facilities in China to process cells and identifying a Chinese principal investigator for the trial.

    2. A major fundraiser is being planned for March 2013 in Hong Kong. We are applying for several possible grants from China.

    3. I will be attending the “The International Neural Regeneration Symposium 2012 (INRS2012)” to be held in Shenyang on September 22-25. Further options for the therapies to be tested in 2014 will be discussed.

    Wise.

  10. #1000
    Quote Originally Posted by Wise Young View Post

    1. We have had several meetings now with the senior leadership of the Ministry of Health in China. They have given us some good and frank advice that we are now scrambling to implement, including setting up facilities in China to process cells and identifying a Chinese principal investigator for the trial.
    Who are currently performing these functions?

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