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Thread: Clinical Trials

  1. #131
    Cheng had a paper published this month describing a Phase 1 trial of acidic FGF:

    Nerve repair using acidic fibroblast growth factor in human cervical spinal cord injury: a preliminary Phase I clinical study.

    Object The aim of this study was to assess functional outcomes of nerve repair using acidic fibroblast growth factor (FGF) in patients with cervical spinal cord injury (SCI). Methods Nine patients who had cervical SCI for longer than 5 months were included in pre- and postoperative assessments of their neurological function. The assessments included evaluating activities of daily living, associated functional ability, and degree of spasticity, motor power, sensation, and pain perception. After the first set of assessments, the authors repaired the injured segment of the spinal cord using a total laminectomy followed by the application of fibrin glue containing acidic FGF. Clinical evaluations were conducted 1, 2, 3, 4, 5, and 6 months after the surgery. Preoperative versus postoperative differences in injury severity and grading of key muscle power and sensory points were calculated using the Wilcoxon signed-rank test. Results The preoperative degree of injury severity, as measured using the American Spinal Injury Association (ASIA) scoring system, showed that preoperative motor (52.4 +/- 25.9 vs 68.6 +/- 21.5), pinprick (61.0 +/- 34.9 vs 71.6 +/- 31.0), and light touch scores (57.3 +/- 33.9 vs 71.9 +/- 30.2) were significantly lower than the respective postoperative scores measured 6 months after surgery (p = 0.005, 0.012, and 0.008, respectively). Conclusions Based on the significant difference in ASIA motor and sensory scale scores between the preoperative status and the 6-month postoperative follow-up, this novel nerve repair strategy of using acidic FGF may have a role in the repair of human cervical SCI. Modest nerve regeneration occurred in all 9 patients after this procedure without any observed adverse effects. This repair strategy thus deserves further investigation, clinical consideration, and refinement.
    ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

  2. #132
    Senior Member Imight's Avatar
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    Quote Originally Posted by Wise Young
    mkusiak,

    To my knowledge, none of the organizations that you name has an approved clinical trial that. Keistead, for example, is working with Geron and that company is still awaiting U.S. FDA approval of the trial. I don't think that Davies is close to a clinical trial for Decorin or GDA BMP; all the work is still preclinical and has some distance to go before clinical trials can start. Cyberkinetics has actually obtained compassionate use approval of the stimulation device but I have not heard that they are actually starting a clinical trial. Likewise, I have not heard that Neuralstem are planning a clinical trial for spinal cord injury.

    The treatments that I know are in or close to clinical trial are:
    • Lithium and cord blood mononuclear cell transplants (ChinaSCINet)
    • Cethrin Phase 2 (Alceres)
    • Bone marrow stem cells (Alok Sharma in Mumbai)

    I will add to this list later.

    Wise.
    Great News!!!!!!!!

    Altho I wonder why Alok charges, while the other 2, do not.

  3. #133
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    Steven,
    That is great news about the study. Thank you for posting.

  4. #134
    Quote Originally Posted by Steven Edwards
    Cheng had a paper published this month describing a Phase 1 trial of acidic FGF:

    Sounds like some pretty robust results...were there 9 subjects involved in applying the procedure, or were there 9 test subjects?
    No one ever became unsuccessful by helping others out

  5. #135
    Senior Member zilnh's Avatar
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    Steven:

    I read this, and although I could understand the gist of it, could you translate it into basic English? I understand the outcome, but some of it went straight over my head and I really want to understand.

    Thanks,
    Liz
    I wished upon a falling star, I wished it had not fallen...

  6. #136
    won't somebody please tell me if the scar can be overriden, then function will return. What is the liklihood of receiving therapies within 5 years from now? It's been a long brutal road since 1999, and I pretty much gave up on therapies in 2006. Something ain't jiving, because promises of clinical trials with humans have come and gone 20 times over.

  7. #137
    Senior Member spidergirl's Avatar
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    Quote Originally Posted by damagedgoods
    won't somebody please tell me if the scar can be overriden, then function will return. What is the liklihood of receiving therapies within 5 years from now? It's been a long brutal road since 1999, and I pretty much gave up on therapies in 2006. Something ain't jiving, because promises of clinical trials with humans have come and gone 20 times over.
    lol. ur in trouble! making chauffeurs waiting at bottom of hill for you....trouble- T R O U B L E! Spell.

    I told you Dr. Stephen Davies has an enzyme (Decorin) that can potentially break down the glial scar. CD! What are you doing?

    Check this out might make you happy....

    Cyberkinetics - Neurotechnology Systems, Inc.

    This is one of many things that are happening. We are getting there and getting closer. In the meantime - advocate and bring as much awareness as you can....no more nonsense w/ plumber folks. Get involved!
    Last edited by spidergirl; 03-22-2008 at 03:47 AM.
    Birds Fly in Flocks, but Eagles Fly Alone...

  8. #138
    Senior Member spidergirl's Avatar
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    Should we not be in clinical trials 2008? This thread is done. We have started yet another year with no successful breakthroughs. I have heard the promises over n over again since late 05' in which people were telling me the same thing- which is when they were injured they kept saying 3-5 years 20 years ago.
    Birds Fly in Flocks, but Eagles Fly Alone...

  9. #139
    Banned adi chicago's Avatar
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    damn before my injury i was a diffrent person....no pain and daily torture.i push myself to stay alive.sci sucks.i need some strong meds to stop my pain and spasticity.every movment or deep breath cause me excruciating spasticity and pain.my whole body hurts like hell and of course depression ocurre .is a burden.
    • Dum spiro, spero.
      • Translation: "As long as I breathe, I hope."

  10. #140
    Quote Originally Posted by spidergirl
    Should we not be in clinical trials 2008? This thread is done. We have started yet another year with no successful breakthroughs. I have heard the promises over n over again since late 05' in which people were telling me the same thing- which is when they were injured they kept saying 3-5 years 20 years ago.
    Perhaps somebody should start a new topic entitled Clinical Trials 2008. Alternatively, I can rename this thread. May I suggest that it is not true that there were no successful breakthroughs in 2007. The finding the cethrin improves recovery in people with spinal cord injury was announced in 2007.

    I have heard rumors that hp184 did not meet their expected primary outcome measure and the new Sanofi-Aventis has decided to can the therapy. In perhaps a month or two, Acorda Therapeutics will announce the second phase 3 result for Fampridine treatment of MS. If positive, this may lead to FDA approval of Fampridine.

    ChinaSCINet finished its phase 1 trial of lithium in 20 patients with chronic spinal cord injury. It suggests that the drug can be reliably titrated to therapeutic levels within about a week, does not cause significant adverse events, and appears to be relatively well-tolerated by people with chronic spinal cord injury.

    Well, there weren't many other clinical treatment trials that we can talk about. The Christopher and Dana Reeve Paralysis Act is still held up by Senator Coburn of Oklahoma for some reason that he has not been kind enough to share. The NIH is still spending less than 1% of its budget on stem cell research. In fact, this year, California will be spending over $300 million on human embryonic stem cell research, more than NIH is spending all human stem cell research, including umbilical cord blood and mesenchymal stem cells.


    Some animal spinal cord injury has been funded by NIH. So, there were a couple of significant breakthroughs there. Lipitor was found to be beneficial for acute spinal cord. This is really the first drug that may be as good or better than methylprednisolone and therefore should be a candidate for clinical trials.

    Induced pluritpotent stem cells were discovered in Japan, first in mice and then in humans. A group in Wisconsin and a group in Kyoto published simultaneously, reporting the forced expression of three genes in human skin cells can cause the cells to adopt embyronic stem cell like behaviors, including production of many different kinds of cells.

    A private group in San Diego announced that they successfully cloned several human blastocysts with a reasonable success rate. This is likely to lead to the announcement of the first cloned human embryonic stem cell line. California has started funding human embryonic stem cells and I think that there will be much progress on the West Coast, progress that can and should have been going on for the past 8 years.

    People are expecting miracles from loaves of bread.

    Wise.

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