The linkurl:Geron Corporation;http://www.geron.com/ linkurl:announced on Tuesday;http://www.geron.com/media/pressview.aspx?id=1187 (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 linkurl:US Food and Drug Administration;http://www.fda.gov/ (FDA) pending the review of some newly submitted animal data.
The study, which linkurl:received clearance;http://www.the-scientist.com/blog/display/55353/ 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...
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New York Times
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