Please Note: THIS FORUM IS PATIENT MODERATED AND IS NOT CONNECTED TO ANY CLINIC OR DOCTOR. IF YOU WISH TO CONTACT A CERTAIN DOCTOR OR CLINIC, PLEASE LOOK IN THE ASK THE DOCTOR SECTION FOR DOCTOR OR CLINIC PHONE NUMBERS AND EMAIL ADDRESSES.

                        Home || Contact Us || Help Registering and Participating || Disclaimer


 SeaChange now offers CBD Oil

 

Barbara and Jeannine's Book

Bea Luis Memorial

 


Results 1 to 2 of 2

Thread: FDA puts Geron's ESC trial for SCI on hold

  1. #1
    Join Date
    May 2007
    Posts
    13,445
    Blog Entries
    5

    Default FDA puts Geron's ESC trial for SCI on hold

    Posted by Jef Akst "The Scientist"
    20th August 2009

    The Geron Corporation announced on Tuesday (August 18) that its stem cell study of spinal cord injury -- the first-ever clinical trial using human embryonic stem cell (hESC)-based therapy -- has been put on hold by the US Food and Drug Administration (FDA) pending the review of some newly submitted animal data.

    The study, which received clearance on January 23 of this year after a 7 month hold by the FDA, aims to treat patients with severe spinal cord injury by injecting hESC-derived progenitors of neural support tissue into the spinal cord. So far, no patients have received the experimental therapy.

    Since Geron submitted its Investigational New Drug application to the FDA in March, 2008, the company has continued to pursue animal studies on the therapy (referred to as GRNOPC1), particularly with regard to increasing dosages and applying the therapy to other neurodegenerative diseases. This week's hold from the FDA came shortly after submitting the data from some of this work.

    Holds on clinical trials are not all that uncommon, especially in cases of novel treatments such as this one, points out The Niche, Nature's stem cell blog: A similar hold was issued by the FDA in February, for example, for a NeuralStem trial on Lou Gehrig's disease. However, given the timing of this hold, it is likely that safety concerns arising from the higher-dosage experiments prompted the move by the FDA, analyst Joseph Pantginis told the New York Times.

    Geron didn't reply to a call requesting comment yesterday. The company stated in a press release that it "will work closely with the FDA to facilitate their review of the new data and to release the clinical hold."
    First treatment in 2007. Pioneering ever since.

    Barbara

  2. #2
    Join Date
    May 2007
    Posts
    13,445
    Blog Entries
    5

    Default Cysts delay Geron trial for SCI

    27th August 2009


    Just over a week after the Geron Corporation announced that the US Food and Drug Administration (FDA) had placed a hold on its stem cell trial aimed at treating patients with spinal cord injury with human embryonic stem cells (hESCs), the company revealed a reason: microscopic cysts.


    The cysts had appeared with a "very low frequency" in previous animal experiments of the drug GRNOPC1, but were "non-proliferative, confined to the injury site, and had no adverse effects on the animals," Geron's statement said. In a more recent animal trial, however, the cysts showed up more often, although again, they were small and did not appear to be harmful in any way. In fact, the statement pointed out, cysts are not uncommon in victims of spinal cord injury, developing in the spinal cord scar tissue in up to 50% of patients.

    "I think it provides people with a reasonable explanation," Stephen Brozak, an analyst with WBB Securities LLC in Westfield, New Jersey, told Bloomberg.com, adding that it was good news that none of the cysts had developed into teratomas.

    Geron is currently working with the FDA to resolve any issues that would prevent the continuation of the trial. "We are committed to the optimization of all our hESC-based products," they said.

    The FDA had no comment, according to spokesperson Karen Riley, saying in an email to The Scientist that they "neither confirm nor comment on clinical holds."
    First treatment in 2007. Pioneering ever since.

    Barbara

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  

Copyright 2007 - 2011 Stem Cell Pioneers