ANN ARBOR – Aastrom Biosciences has expanded the U.S. Phase I/II clinical trial of its adult stem cell-based Tissue Repair Cells in the treatment of severe long bone non-union fractures to include the Department of Orthopedic Surgery at William Beaumont Hospital, the third U.S. site engaged in the trial.
The Principal Investigator for Beaumont, Dr. Gregory Nowinski, will be joined by Dr. Patrick Wiater and Dr. Jeffrey Balazsy. All of the investigators practice in the Detroit-metro area, and are affiliated with the Department of Orthopedic Surgery at Beaumont, under the direction of Department Chair, Harry Herkowitz, M.D. Patients will be recruited into the study immediately.
The other two sites for the trials are Lutheran General Hospital of Chicago and the University of Michigan Health System in Ann Arbor.
Aastrom’s TRC bone graft product is also under evaluation in long bone fracture clinical trials in Bochum, Germany, and Barcelona, Spain. As a result of positive initial results in the Barcelona study, Aastrom recently announced plans to expand that trial for these severe fracture indications to accrue additional patients. The TRC product is also in a clinical trial in Barcelona for the treatment of sinus lift bone graft procedures, to generate new bone tissue in the maxillary jaw bone.
