FDA Negotiates with Geron to End Hold


Geron Corporation has negotiated with the Food and Drug Administration to continue their Phase I trial with their embryonic stem cell-derived cell line GRNOPC[1].  To refresh your memories, As announced previously, in one preclinical study, in a preclinical study, Geron scientists saw a higher frequency of cysts in animals treated with GRNOPC[1] cells.  These cysts formed in the injury site, do not grow (are non-proliferative), are confined to the injury site, are smaller than the injury cavity, and do not seem to cause any adverse effects in the animals.  The FDA placed a hold on Geron’s Investigational New Drug Application in response to these data.

Geron apparently made a deal with the FDA to continue preclinical studies with some “new markers and assays” as agreed upon in discussions with the FDA.  Geron also said in their news release that as a “part of the ongoing plan to advance clinical development to cervical patients, Geron had already initiated this preclinical study in an animal model of cervical injury.”  They also say that Geron hopes that the study will be re-initiated in the third quarter of 2010.

Geron hopes to use their cell line to treat spinal cord injury to the cervical (upper) portion of the spinal cord as well as the thoracic (middle) portion of the spinal cord.

I hope that Geron gets this off the ground.  They have worked very hard and if their cell line helps people with spinal cord injury, then that’s great.  However what I hope we do not see are more embryos killed so that others can experiment with their cells.  In the case of Geron’s cell line, the embryos were killed long ago.  Whining about it seems to be completely counterproductive.  However if these cells can help people, then great.

We should not be surprised that there are concerns with these treatments.  It is after all, the first of its kind.  There are bound to be glitches.

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mburatov

Professor of Biochemistry at Spring Arbor University (SAU) in Spring Arbor, MI. Have been at SAU since 1999. Author of The Stem Cell Epistles. Before that I was a postdoctoral research fellow at the University of Pennsylvania in Philadelphia, PA (1997-1999), and Sussex University, Falmer, UK (1994-1997). I studied Cell and Developmental Biology at UC Irvine (PhD 1994), and Microbiology at UC Davis (MA 1986, BS 1984).