BONE GRAFT CLINICAL TRIAL EXPANDED

Aastrom Biosciences announced that it has expanded the U.S. Phase I/II clinical trial of its adult stem cell-based Tissue Repair Cells (TRCs) in the treatment of severe long bone open or non-union fractures to include the University of Nebraska Medical Center (UNMC) in Omaha, Neb. This is the fifth site now engaged in this U.S. multicenter trial, which is already underway at Lutheran General Hospital, Park Ridge, Ill., the University of Michigan Health System, Ann Arbor, Mich., William Beaumont Hospital, Royal Oak, Mich., and Lutheran Medical Center, Brooklyn, N.Y.

Patients suffering with either long-term, non-healing, or appendicular (fresh) non-union tibial fractures may be eligible to enroll in this study. The clinical procedure begins with the collection of a sample of bone marrow from the patient's hip in an outpatient setting. The adult stem cells (unspecialized cells) and progenitor cells (partially specialized cells) derived from the bone marrow are placed in the AastromReplicell System where TRCs are produced over a 12-day period. These TRCs are then inserted back into the patient at the fracture site, in an operating room procedure. These cells are designed to act as bone forming cells and promote healing of the open or non-union fractures.