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Thread: Protect Stem Cell Science from Stem Cell Quackery

  1. #1

    Thumbs up Protect Stem Cell Science from Stem Cell Quackery

    (Keep the Opportunities, Lose the Opportunists) by Graham Parker, Ph.D. and Jeanne F. Loring, Ph.D.

    See the Full Article HERE at Genetic Engineering and Biotechnology News.

    On September 12th-13th (9AM-5PM) Eastern Standard Time, the FDA will hold a two day public hearing on their proposed changes to regulations of stem cell therapies. This meeting, called Part 15 Hearing on Draft Guidance's Relating to the Regulation of HCT/Ps [Human Cells, Tissues, and Cellular and Tissue-Based Products], will be held at the NIH headquarters in Bethesda, MD. There are 54 clinics or organizations scheduled to speak at this meeting and forty individuals.

    Agenda: LINK

    Persons (including FDA employees) seeking to view the hearing via a live Webcast are not required to register. A link to the Webcast will be made available on this web page on the day of the hearings. A video recording of the proceedings will be available for one year at the same web page link.
    Last edited by GRAMMY; 09-03-2016 at 06:31 PM. Reason: spelling

  2. #2
    I have no other hope. The naysayers can back off. This is not directed at you Grammy.
    Last edited by nonoise; 09-03-2016 at 05:05 PM.
    I have had periodic paralysis all my life. I lost my ability to walk in 2011 beginning with a spinal block, which was used for a hip fracture caused by periodic paralysis.

  3. #3
    Some stem cell clinics are sanctioned by NIH as noted in this upbeat article about a paralyzed stem cell patient:
    http://pilotonline.com/news/local/pa...1c0e602c7.html
    I have had periodic paralysis all my life. I lost my ability to walk in 2011 beginning with a spinal block, which was used for a hip fracture caused by periodic paralysis.

  4. #4
    Quote Originally Posted by nonoise View Post
    Some stem cell clinics are sanctioned by NIH as noted in this upbeat article about a paralyzed stem cell patient:
    http://pilotonline.com/news/local/pa...1c0e602c7.html
    And therein lies the rub on enticements with skewed media reporting. The clinic was running a COPD trial listed on Clinical Trials.gov but that shouldn't now be viewed as an NIH "endorsement" for selling SCI patients fat derived stem cell treatments that may not meet GMP or FDA guidelines and proven effective in organized trials.

    http://www.npr.org/sections/health-s...ell-treatments

    https://www.washingtonpost.com/news/...cross-the-u-s/

    https://www.statnews.com/2016/02/08/...-cell-clinics/

    http://www.nature.com/news/boom-in-unproven-cell-therapies-intensifies-regulatory-debate-1.20545

    (Berman and Propis neither one charged paralyzed patients in these media stories because they have no idea if the treatment will actually work).
    Last edited by GRAMMY; 09-07-2016 at 07:52 PM. Reason: spelling

  5. #5
    Quote Originally Posted by GRAMMY View Post
    And therein lies the rub on enticements with skewed media reporting. The clinic was running a COPD trial listed on Clinical Trials.gov but that shouldn't now be viewed as an NIH "endorsement" for selling SCI patients fat derived stem cell treatments that may not meet GMP or FDA guidelines and proven effective in organized trials.

    http://www.npr.org/sections/health-s...ell-treatments

    https://www.washingtonpost.com/news/...cross-the-u-s/

    https://www.statnews.com/2016/02/08/...-cell-clinics/

    (Berman and Propis neither one charged paralyzed patients in these media stories because they have no idea if the treatment will actually work).
    Thanks for looking in to it Chris, this is why I love and look forward to your posts! I don't have much knowledge of these things but I can trust you to point out the bullshit that goes on in SCI research etc. BTW, I've been visiting your research and advocacy site without fail! Thanks for what you do!

    Regards

  6. #6
    same here Grammy. Thank you for all the work.

  7. #7
    Quote Originally Posted by taymas View Post
    Thanks for looking in to it Chris, this is why I love and look forward to your posts! I don't have much knowledge of these things but I can trust you to point out the bullshit that goes on in SCI research etc. BTW, I've been visiting your research and advocacy site without fail! Thanks for what you do!

    Regards
    Absolutely, thank you for your support and strong
    leadership.
    "I'm manic as hell-
    But I'm goin' strong-
    Left my meds on the sink again-
    My head will be racing by lunchtime"

    <----Scott Weiland---->

  8. #8
    The webcast is in process today and tomorrow at this link page.

  9. #9
    Day 1 Video Testimony LINK if you missed the live feed on day one.

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