The Geron Corporation could be cleared to resume its stalled human embryonic stem cell (hESC)-trial for spinal cord injury in the third quarter of next year, linkurl:the company announced today;http://www.geron.com/media/pressview.aspx?id=1195 (October 30).
The Phase I trial, which received clearance from the US Food and Drug Administration (FDA) in January to administer hESC-derived progenitors of neural support tissue into the spinal cords of patients with severe spinal cord injury, is the first-ever clinical trial of a hESC-based therapy. In August, however, before any patients could receive treatment, the FDA put the trial linkurl:on hold after cysts appeared;http://www.the-scientist.com/blog/display/55950/ in some of the animals that had been given the treatment as part of a preclinical study. Since then, Geron has continued its preclinical study of the treatment, using new markers and assays agreed upon with the FDA, according to their press release. If the...
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