Bone Repair

FDA approval granted to initiate trial for bone graft product

Published in Blood Weekly, September 25th, 2003

Aastrom Biosciences, Inc., (ASTM) announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a multicenter phase I/II clinical trial for the company's bone generation Tissue Repair Cell (TRC) stem-cell product.

The study allows Aastrom's TRCs to be used at up to three centers for the treatment of tibial non-union fractures, and could lead to a viable alternative to the current, highly morbid standard of treatment for use in the multi-million dollar bone graft market. The approval of the IND represents a key milestone that supports Aastrom's focus on the use of its stem cell-based TRCs for tissue...

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Source: Blood Weekly (2003-09-25)

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