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Thread: UCB clinical trials lag vs Embryonic, Fetal and Other Stem Cells for Spinal Injury

  1. #1

    UCB clinical trials lag vs Embryonic, Fetal and Other Stem Cells for Spinal Injury

    So far there are 3 US company originated clinical trials taking place for spinal cord injury (all started this year)

    1. with bone marrow derived stem cells. An Irak Veteran was first to be enrolled:
    For Chronic SCI

    2. with embryonic derived stem cells. An anonymous recipient at Sheppard's in Atlanta was the first to be enrolled:
    For Acute SCI

    3. with fetal derived neural stem cells. First patient to be enrolled in Switzerland in 2011 as preliminary approvals have been granted.
    For Chronic SCI

    I checked Stemcyte for umbilical cord blood stem cells but only found this in a 2008 Press Release:
    "hope to treat our first patient in clinical trials later this year"
    For Chronic SCI

    and this in 2010:
    The Patient Protection and Affordable Care Act of 2010 (PPACA) created the QTDP [COLOR=blue !important][COLOR=blue !important]program[/COLOR][/COLOR] as a means to support qualified research and development projects that show significant potential to produce new and cost-saving therapies, support job growth and increase U.S. competitiveness, the Company noted. Following a competitive application process, StemCyte was awarded two grants for advance therapies using UCB stem cells for the potential treatment of chronic [COLOR=blue !important][COLOR=blue !important]spinal [COLOR=blue !important]cord [/COLOR][COLOR=blue !important]injury[/COLOR][/COLOR][/COLOR] and chronic stroke.

    Are they just doing research and development or have they enrolled any patients at all in clinical trials?

    Note that 1., 2., 3. have designed their clinical trials to enroll just 10-20 patients to quickly and cost efficiently determine safety in the stage 1 clinical trials.
    Last edited by Pro-SCNT; 11-17-2010 at 12:48 PM.

  2. #2
    Pro-SCNT; the Geron trial is for acutes within 2 weeks of injury and the others you mentioned hopefully will be for chronics. they're starting and there will be more in the upcoming year.

    keeping on

  3. #3
    It took a little digging but here is an update for the umilical cord blood derived stem cell clinical trial using the Stemcyte product:

    This trial was started in early March 2010.

    The trial details have been posted on Briefly, the trial will recruit 20 subjects with chronic traumatic spinal cord injury at C5 and T10 levels inclusive (more than one year after injury with stable neurological function); who are classified on the ASIA Impairment Scale as A (“complete” spinal cord injury); who do not have significant contraindications to the surgery, methylprednisolone or lithium; and for whom we can find an umbilical cord blood unit that matches at least 4:6 human leukocyte antigens (HLA) -A, -B, and -DR. The institutional review boards (IRB) of HKU and CUHK, and Hong Kong Department of Health have approved the trial.

    The subjects will be enrolled into five treatment groups and four subjects for each group.

    StemCyte, a US cord blood bank, will donate the HLA-matched human umbilical cord blood cells.

    Not sure if the first patient has yet been enrolled though. As of August that still was not the case.

    keeping on, I had already indicated which clinical trials were for chronic SCI vs acute.

    They are all for chronic sci except for the Geron trial.

    Adult stem cell research still has a 9 to 1 advantage in federal funding, so it is still very surprising to see so few adult stem cell clinical trials up and running for spinal cord injury.

    The route for small clinical trials is well-represented though.

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