Thread: ChinaSCINet Update

  1. #2091
    What exactly does the "compassionate use" allow to happen?
    Thanks for keeping us all up to date and doing so well with answer questions Jim.

  2. #2092
    Senior Member Moe's Avatar
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    Happy Birthday ChinaSCINet Update Thread... In a few hours you'll be exactly 4 years old...

  3. #2093
    Once this is published, is this going to be everywhere, news, Internet, articles everywhere? Is that going to be the goal, or is it going to be more low key like other spinal cord injury research articles none of which have been this successful I may add.

  4. #2094
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    If Wise gets compassionate use for his therapy. Would it prevent another company from getting it? Neural stem, Stem Cells Inc, etc..

  5. #2095
    Quote Originally Posted by #LHB# View Post
    If Wise gets compassionate use for his therapy. Would it prevent another company from getting it? Neural stem, Stem Cells Inc, etc..
    No.

    “…FDA has demonstrated its commitment to supporting access to experimental therapies for patients living with serious diseases. The agency is an important part of the process, helping to ensure that patients are protected from potentially harmful drugs or one that doesn't work. Allowing access to investigational therapies requires the cooperation of others, including drug companies and doctors, not just FDA. In cases where a company has initially denied access, FDA has stepped in to help. FDA is proud of its record facilitating access to safe, effective therapies for patients who need them as quickly as possible.” - Margaret Hamburg: Commissioner, U.S. FDA -

    See more at: http://www.neuralstem.com/neuralstem....uynn965V.dpuf

  6. #2096
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    Quote Originally Posted by GRAMMY View Post
    No.

    “…FDA has demonstrated its commitment to supporting access to experimental therapies for patients living with serious diseases. The agency is an important part of the process, helping to ensure that patients are protected from potentially harmful drugs or one that doesn't work. Allowing access to investigational therapies requires the cooperation of others, including drug companies and doctors, not just FDA. In cases where a company has initially denied access, FDA has stepped in to help. FDA is proud of its record facilitating access to safe, effective therapies for patients who need them as quickly as possible.” - Margaret Hamburg: Commissioner, U.S. FDA -

    See more at: http://www.neuralstem.com/neuralstem....uynn965V.dpuf
    Good to no. Thanks GRAMMY.

  7. #2097
    Quote Originally Posted by Barrington314mx View Post
    What exactly does the "compassionate use" allow to happen?
    Thanks for keeping us all up to date and doing so well with answer questions Jim.
    Access to Investigational Drugs Outside of a Clinical Trial (Expanded Access)

    Quote Originally Posted by JamesMcM View Post
    Once this is published, is this going to be everywhere, news, Internet, articles everywhere? Is that going to be the goal, or is it going to be more low key like other spinal cord injury research articles none of which have been this successful I may add.
    I think it will prob be low key because it occurred in China. One reason to apply for Compassionate Use is to prevent sham clinics from opening up all over the world. These places don't generally have GMP cells, and they sure won't have qualified surgeons.

  8. #2098
    Senior Member Imight's Avatar
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    I had no idea you'd been out here to china. makes a lot of sense now. hows it going Jim?

  9. #2099
    I went to China about 4-5 yrs ago, before you moved there. How is everything, you owe us an update

  10. #2100
    Is this the same approach or how is this different from ChinaSCINET? Are they using different type of cells? what determines what types of stem cells would be the best for SCI? How many types are there to be tried? Do we know?

    http://www.cirm.ca.gov/about-cirm/ne...l-trial-funded

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