Thread: ChinaSCINet Update

  1. #1821
    Dear Dr Young,
    do you think Lokomat could be helpful for rehabilitation?
    Thanks. Best wishes.

    http://web.ethlife.ethz.ch/e/article...ife/armin.html

  2. #1822
    Dear Dr Young,
    do you think Lokomat could be helpful for rehabilitation?
    Thanks. Best wishes.

    http://web.ethlife.ethz.ch/e/article...ife/armin.html

  3. #1823
    Is that December or January estimate for US IND application submission to FDA still looking possible? :popcorn:

  4. #1824
    Senior Member lunasicc42's Avatar
    Join Date
    Oct 2004
    Location
    Lutz, Fl USA*********C456
    Posts
    2,364
    Quote Originally Posted by Barrington314mx
    Is that December or January estimate for US IND application submission to FDA still looking possible? :popcorn:
    yeah?

  5. #1825
    We are not using Lokomat because it cannot be used for extended periods, such as 6 hours a day. Wise.

  6. #1826
    We are working on getting the papers published and preparing the IND. I don't think that we will be able to get the IND application this December. We will try to get it in as soon as possible. Wise.

  7. #1827
    Do you expect the phase 3 trial start within the first half of 2014?

  8. #1828
    No, I do not expect the phase III trial to start within the first half of 2014. It will likely be Q3. Wise.

  9. #1829
    I just came from China. The establishment of validated cell processing laboratories in China is a necessary step for approval of CN103, the phase III clinical trial. Three centers have agreed to do the cell processing and to train to do so at Stemcyte, Vista Biologics, and Rutgers in January 18-25, 2014. This was postponed from November 2013 due to difficulties and delays in getting U.S. visas for everybody. Since Chinese New Year will be January 31, this means that none of the laboratories will be able to do anything until after the Chinese New Year. They will have to set up their laboratories, get all their personnel together, and ultimately practice doing processing the units from March to April. In May or June, they will participate in formal validation studies. If they pass, we will submit the data to the Chinese FDA along with the IND (application) for the trial.

  10. #1830
    Wow, it's quite the process huh Dr. Young? Well, keep up the slow steady march, sounds like wheels are in motion.

Similar Threads

  1. ChinaSCINET Update
    By Schmeky in forum Cure
    Replies: 11
    Last Post: 06-16-2008, 06:25 PM
  2. ChinaSCINET on Schedule?
    By Schmeky in forum Cure
    Replies: 11
    Last Post: 01-27-2008, 05:53 AM
  3. Dr. Young and ChinaSciNet
    By Imight in forum Cure
    Replies: 17
    Last Post: 01-14-2008, 12:51 AM
  4. ChinaSCINET Schedule
    By Schmeky in forum Cure
    Replies: 4
    Last Post: 07-11-2007, 04:30 AM
  5. ChinaSCINET, On Schedule?
    By Schmeky in forum Cure
    Replies: 56
    Last Post: 01-30-2007, 03:46 PM

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •