Nearly a year after the US Food and Drug Administration placed a hold on the first clinical trial of human embryonic stem cells, the company linkurl:Geron;http://www.geron.com/ has been cleared to continue its study of spinal cord injury, linkurl:it announced today;http://www.geron.com/media/pressview.aspx?id=1229 (July 30).
"We are pleased with the FDA's decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed," Geron's president and CEO Thomas Okarma said in a statement. The Phase I trial, which aims to use human ESC-derived progenitors of neural support tissue to treat patients with severe spinal cord injury, was to be the first-ever clinical trial of a hESC-based therapy when it was cleared by the FDA in January 2009. That August, however, before any patients had received treatment, the FDA linkurl:placed a hold;http://www.the-scientist.com/blog/display/55898/ on the trial after linkurl:cysts appeared;http://www.the-scientist.com/blog/display/55950/ in some of the...
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