FDA approves first embryonic stem cell clinical trial

Posted by ERV on August 1, 2010
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Geron press release:

“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged – to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer’s, multiple sclerosis and Canavan disease.”

As Randy Marsh would say “I LOVE THE FUTURE!!!”

OMFG I LOVE BEING ALIVE NOW!! We can do, and are going to be able to do, the COOLEST STUFF! This is the road to curing spinal cord injuries. AHHHHHHHHH!!!

Now, if I only had my goddamn hover-car…

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Comments

  1. #1 Jeb, FCD
    August 1, 2010

    I’ve been wondering for a few years where my freakin’ jet-pack is.

  2. #2 sadpanda
    August 1, 2010

    Just watched Daniel Kraft’s talk at TEDMED 2009 ( http://www.youtube.com/watch?v=SORBWMZKX9w ) where this was one the things mentioned and then I read this, nice coincidence. :)

  3. #3 interkin3tic
    August 1, 2010

    Honestly, I’m a little more skeptical about this for a few reasons highlighted in this article. There’s the possibility that these cell cultures won’t be completely differentiated when they’re injected and they’d make tumors, which was found in the animal models. That was the reason for the hold. There’s also immune rejection issues, they’re anticipating that these patients will only have to be on immunosupressive drugs for a while, and after that the blood-brain barrier will prevent immune system rejection, so I guess that’s not much of a concern here. Lastly, this is a company that by some accounts is jumping the gun to make a profit, that’s always disconcerting.

    I’m a little more excited about epidermal neural crest stem cells. Like this treatment, they’ve been shown to restore function to damaged spinal cords in mouse models, but unlike hESC, they can be obtained from the patient, allowing for autologous transplants that wouldn’t risk immune rejection, and they apperantly don’t form cysts or tumors.

    That said, I’ve only read that one article about EPI-NCSC. I don’t know why trials aren’t going ahead with them instead of hESC, there might be very good reason for that. I suspect though it’s just a case of “there’s no patentable product to be sold there, so there’s less interest to spend money developing it as a treatment.”

  4. #4 Brian
    August 2, 2010

    I’ll take this stuff over a hovercar any day.

  5. #5 Paul Browne
    August 2, 2010

    This is exciting news indeed, and it’s reassuring to see that they are taking a lot of care in evaluating the preclinical data before going to clinical trails

    I wrote a post about this back in January 2009 when Geron first announced the trial, it’s good to see that it’s back on.

    http://speakingofresearch.com/2009/01/23/a-new-era-for-embryonic-stem-cells/

    I’d add that promising results have also been obtained using olfactory ensheathing cells in animal models of spinal damage, and one clinicl trial which assessed the safety of the technique, time since injury was too long to expect significant improvement, has been performed http://dx.doi.org/10.1093/brain/awn173 The Geron trial will involve patients who have been injured more recently (within 14 days) and will assess efficacy.

    Like the epidermal neural crest cells described by interkin3tic they have the advantage that they use cells derived from the patient themselves, thus avoiding the need for immunosuppression, though it’s worth noting that ESc’s are immunologically privilaged and the Geron trial only plans to use low-dose immunosuppression for 60 days after transplant.

  6. #6 Scientizzle
    August 2, 2010

    OT: the NIH is going to hold 1st International Workshop on XMRV: Pathogenesis, Clinical and Public Health Implications on September 7-8 in Bethesda. erv should defintiely go…

  7. #7 Scientizzle
    August 2, 2010

    This clinical trial is very interesting news, indeed. I always worry about this cutting-edge stuff, though, because all it takes in one unfortunate Jesse Gelsinger to scare the bejeezus out of everyone and set some area of clinical research back a decade…

  8. #8 Tones
    August 5, 2010

    I thought this had been going on for years over here ??? UK

  9. #9 NDJS
    August 6, 2010

    Quality of life prevaling over quantity.
    finally.

  10. #10 scramton
    August 8, 2010

    You can have your hovercar too Terrafugia

  11. #11 dell
    September 12, 2010

    how do i sign up to be a crash test dummie? i mean can i get some free samples somewhere or something, i inherited scolisios from my granny i’ve been waiting for something like this i’m not sure it’s even on my expensive insurance anyway