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Thread: Spinal Cord Injury Network USA (SCINetUSA)

  1. #421
    Quote Originally Posted by lunasicc42 View Post
    But aren't they 'in sight '? I agree that it sux that we have not been told any concrete start dates but there are centers that already have agreed to carry out the trials . Things are still moving along , although I admit , not fast enough for your or my liking .....things are still going . Nothing has stopped

    Jim or wise, I know that this has probably already been asked in the past but what has changed ? I mean what centers agree to be part of Scinetusa as of today and Hows the timeline look for when those centers will start recruiting and carrying out operations?
    If you can see them you must have info I don't have or a good telescope - LOL!

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  2. #422
    Senior Member lunasicc42's Avatar
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    OK I see what you are saying . What I was trying to convey is that there are hospitals that have agreed to carry out the trials. Isn't that something ?...so it's Apparently going to happen ...just not as soon as we want
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


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  3. #423
    Quote Originally Posted by Jim View Post
    Wise has been crystal clear from the beginning; the ChinaSCINet Phase II Trial had to be completed and the paper published before we could apply to the US FDA for Phase III approval. We had hoped to start the Trial in the 3rd quarter of '14 but it will not happen until next year.

    All of the centers are on the East Coast, think there are 4 but I am not sure of the 'official' list.
    I may have missed something. Wasn't there going to be a phase II trial of 20 subjects in the US before you did a phase III in the US?

  4. #424
    Senior Member lunasicc42's Avatar
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    Quote Originally Posted by Nowhere Man View Post
    I may have missed something. Wasn't there going to be a phase II trial of 20 subjects in the US before you did a phase III in the US?

    They are Apparently using the phase 2 trial in china and using those safety results to apply for the phase 3 in the usa, thats the impression that I had
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  5. #425
    It doesn't seem like it but has the US pHASE 3 trials happened?

  6. #426
    The Phase II safety study was completed in ChinaSCINet, (28 subjects). Those results were used to apply for the upcoming Phase IIb trials in India, Taiwan, and the US. Will be 27 in US trial.
    Last edited by Jim; 03-16-2017 at 08:49 AM.

  7. #427
    Thanks Jim. I know there are a lot of unforeseen factors that make it hard to say but is there any rough timeline on those trials starting?

  8. #428
    We are hoping to start the US trial this fall.

    Taiwan and India should start sooner.

  9. #429

    !

    Quote Originally Posted by Jim View Post
    We are hoping to start the US trial this fall.

    Taiwan and India should start sooner.
    Hope it's early fall! Is the trial only for acutes or the completely paralyzed? -Jan

  10. #430
    Dr. Young is committed to developing therapies for chronics (injured more than 1 year).

    The subjects in the ChinaSCINet trial averaged 7 years after injury, the longest, 17 yrs.

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