Drug Development
Phase I/II trial initiated for bone formation therapy in the spine
Published in Medical Letter on the CDC and FDA, January 1st, 2006
The phase I/II trial will be conducted under an Investigational New Drug (IND) application approved by the U.S. Food and Drug Administration (FDA), and initially conducted at a single clinical center, the William Beaumont Hospital in Royal Oak, Michigan (Beaumont Hospital).
Aastrom's TRCs, a proprietary bone marrow-derived adult stem cell product, will be used in posterior-lateral lumbar spinal fusions for treatment of degenerative spondylolisthesis. This is the...
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