The FDA has approved the first trial of a therapy derived from embryonic stem cells. The trial--run by Menlo Park, CA-based Geron--will test GRNOPC1 in patients with acute spinal cord injury. The company will enroll paraplegic study subjects who will receive a single stem cell injection in the spine less than two weeks after being injured. The primary endpoint of Geron's Phase I study will be to assess the safety of the injection. However, it will also watch for evidence that the procedure improves patients' conditions, such as improved neuromuscular control or sensation in the trunk or lower extremities.
"This marks the beginning of what is potentially a new chapter in medical therapeutics--one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells," the company said in a statement. "The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord."
The study marks the first time an embryonic stem cell trial has been approved in the U.S. ESC research has a long and politically charged history here, with conservatives objecting to using embryonic cells for medical testing purposes. President Bush used his first-ever veto to reject a 2006 bill on embryonic stem-cell research that would have lifted the 2001 ban on public funding of stem cell research. However, President Obama has stated that one of his first moves will be to lift the funding ban that has stifled ESC research in the U.S.
- see Geron's release
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