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Aastrom received FDA approval to initiate multi-center trial for bone graft product.

Aastrom Biosciences, Inc., Ann Arbor, MI, announced that the FDA has approved its Investigational New Drug (IND) application for a multi-center Phase I/II clinical trial for the company's bone generation Tissue Repair Cell (TRC) stem cell product. The study will allow Aastrom's TRCs to be used at up to 3 centers for the treatment of tibial non-union fractures. The company says if the trial is successful it could lead to a viable alternative to the current, highly morbid standard of treatment for use in the multi-million dollar bone graft market.

Aastrom says the bone graft trial protocol will combine its TRCs with a standard orthopedic matrix, to be provided by the Musculoskeletal Transplant Foundation (MTF), Edison, NJ. The company anticipates the trial will be conducted concurrently with other planned trials in Europe that are intended to demonstrate the safety and efficacy of TRSs for bone graft indications.

Contact: Becky Anderson - (734) 930-5777, Web site: www.aastrom.com.
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Title Annotation:Aastrom Biosciences Inc.
Publication:Transplant News
Article Type:Brief Article
Geographic Code:1USA
Date:Sep 15, 2003
Words:158
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