Thread: ChinaSCINet Update

  1. #2311
    Quote Originally Posted by #LHB# View Post
    Dr. Young could you give us an update on what's going on in your trial? Haven't had an update in a while, when will your work be published?
    I am working with a CRO to prepare the applications for trials. It is a slow process and a lot of work. We are considering doing phase II trials in some countries. The paper submission was delayed because some of the authors of the paper requested a delay in order to add some changes to the DTI studies in the manuscript. We will submit it as soon as possible. Wise.

  2. #2312
    Quote Originally Posted by Wise Young View Post
    I am working with a CRO to prepare the applications for trials. It is a slow process and a lot of work. We are considering doing phase II trials in some countries. The paper submission was delayed because some of the authors of the paper requested a delay in order to add some changes to the DTI studies in the manuscript. We will submit it as soon as possible. Wise.
    Hi Doctor.... I take it we won't go ahead with this year too (Phase III)? Or do you mean there WILL be Phase III, but some countries would require Phase II? If so, what countries and why? So will it be 2016? I was hoping 2013 (already gone lol)... If only this rigorous procedure to get approval was easier. Let us know, good luck and thank you. Sorry for all the questions!

  3. #2313
    Quote Originally Posted by taymas View Post
    Hi Doctor.... I take it we won't go ahead with this year too (Phase III)? Or do you mean there WILL be Phase III, but some countries would require Phase II? If so, what countries and why? So will it be 2016? I was hoping 2013 (already gone lol)... If only this rigorous procedure to get approval was easier. Let us know, good luck and thank you. Sorry for all the questions!
    Taymas,

    We are working on regulatory approval of the clinical trials in China (including Hong Kong and Taiwan), India, Norway, and the U.S. China is right now the most unclear because they have recently changed and appear to be changing their regulations again. India has also changed their regulations so that the DCGI (Director Controller General of India) is taking over clinical trials approval from ICMR (Indian Council of Medical Research) and we have heard that the government of Narendra Modi has placed stem cells high on its priority list and will be adopting the Japanese policy of providing conditional market approval of stem cell therapies after positive phase II trials. We therefore have proposed to do phase IIb trials in China and India. In the U.S. and Europe, if the phase III trials appear to take longer than 2015 for approval, we are also considering doing some phase II trials before the Phase III start. Finally, we are planning to apply for expanded access compassionate use in the U.S. and Europe alongside the phase III trial. It is hard to predict what will happen and I will post information as soon as we know. Wise.

  4. #2314
    Quote Originally Posted by Wise Young View Post
    Taymas,

    We are working on regulatory approval of the clinical trials in China (including Hong Kong and Taiwan), India, Norway, and the U.S. China is right now the most unclear because they have recently changed and appear to be changing their regulations again. India has also changed their regulations so that the DCGI (Director Controller General of India) is taking over clinical trials approval from ICMR (Indian Council of Medical Research) and we have heard that the government of Narendra Modi has placed stem cells high on its priority list and will be adopting the Japanese policy of providing conditional market approval of stem cell therapies after positive phase II trials. We therefore have proposed to do phase IIb trials in China and India.
    Dr. Young,

    Could you briefly explain what the difference is between phase IIb and phase III trials? Are phase IIb trials more likely to be approved in China? Will there be phase III trials later in China? Thank you.
    It's a shame of human beings that SCI cannot be cured.

  5. #2315
    Quote Originally Posted by suguo View Post
    Dr. Young,

    Could you briefly explain what the difference is between phase IIb and phase III trials? Are phase IIb trials more likely to be approved in China? Will there be phase III trials later in China? Thank you.
    Suguo,

    Phase IIb and phase III trials are trials that are aimed at determining efficacy. IIa trials are aimed at determining the best outcome or dose. III trials are "pivotal" trials, usually multicenter randomized clinical trials that provide the data that regulatory agencies will base their approvals.

    In China, there are two types of phase III trials. The first are trials carried out by researchers at hospitals and the hospital is approved to apply that therapy to people. While most of these trials are testing so-called "medical technology" rather than products, several cell transplants trials have been approved in this category.

    The second are trials sponsored by pharmaceutical or biotechnology companies to obtain approval of registered products for sale. The China Food and Drug Administration (cFDA) tends to be tough and impose rigorous manufacturing and quality control requirements on the company.

    China does not allow any foreign company to produce stem cell products in China. Since Stemcyte does not have a company in China, we are applying for hospital-based approvals. Stemcyte will have to partner with a Chinese company for manufacturing and marketing.

    Phase III product registration trials tend to take the longest to negotiate and obtain approval for. In general, hospital based phase IIb and III trials should be approved more quickly. We have trained three hospitals in China to process the cells.

    Wise.
    Last edited by Wise Young; 03-18-2015 at 01:39 AM.

  6. #2316
    Dr. Young will any of these clinical trials be open to foreign patients? And will each location include the walking program or just the one in china?

  7. #2317
    Dr young do you have any news about the publication? or when finaly the phase 3 starts??

  8. #2318
    Quote Originally Posted by athanasios View Post
    Dr young do you have any news about the publication? or when finaly the phase 3 starts??
    *tumbleweed*

    Jokes aside I would love to know too!

  9. #2319
    He's answered that question many times they've said anything new will be posted on here first thing, so we just have to wait I know that's hard but I'm sure he's a very busy man, dealing with no simple task. I would like to know about if the walking program will be done in other sites not just China, but I imagine something like that in the states is very pricey. And If foreigners will be able to enroll in any of these clinical trials, these questions haven't been addressed yet, and at this point may not have an answer yet.
    Last edited by JamesMcM; 04-21-2015 at 12:19 PM.

  10. #2320
    Quote Originally Posted by JamesMcM View Post
    He's answered that question many times they've said anything new will be posted on here first thing, so we just have to wait I know that's hard but I'm sure he's a very busy man, dealing with no simple task. I would like to know about if the walking program will be done in other sites not just China, but I imagine something like that in the states is very pricey. And If foreigners will be able to enroll in any of these clinical trials, these questions haven't been addressed yet, and at this point may not have an answer yet.
    James, if I remember right Dr. Young has stated in the past that foreigners would not be allowed to participate in the China trials. I think he mentioned U.S. costs would likely be around 100k, 40k in China if the treatment comes to pass. It'd be in this thread if you'd like to search for it.


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