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Stem cell technology showing promise for healing nonunion fractures

Researchers found callus formation in 78% of patients by 3 months after treatment with Aastrom Biosciences' Tissue Repair Cells.

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Preliminary data from early stage clinical trials suggest a novel biologic product that uses adult stem and progenitor cells derived from bone marrow can aid in healing nonunion of long-bone fractures, according to a press release from the technology's developer.

Aastrom Biosciences Inc. announced interim results of a phase 1/2 trial evaluating its Tissue Repair Cells (TRCs) in 36 patients. The analysis included data for 23 patients with at least 6 months' follow-up, including 12 patients who completed final follow-up at 1 year.

All 23 patients had atrophic nonunion of a long bone fracture (leg or arm) that failed to heal after prior bone grafting and surgical treatments; 10 patients had failed two to three previous treatments and 10 patients were smokers.

At 3 months' follow-up, researchers found that treatment with TRCs led to callus formation in 78% of the 23 patients, which increased to 96% by 6 months. Of the 12 patients with 1-year follow-up, 10 showed bone bridging at the fracture site as well as radiographic evidence of healing, according to the release.

Investigators also reviewed data for 15 patients in two subgroups who completed clinical examination surveys with their physicians. At 1 year, six of seven patients in the first subgroup and eight of eight patients in the second subgroup had returned to weight-bearing mobility, according to the release.

Janet Hock, BDS, PhD, vice president of Global Research and chief scientific officer of Aastrom, and Thomas R. Lyon, MD, chief of orthopedic trauma and a clinical instructor of orthopedic surgery at Lutheran Medical Center, New York City, conducted the study with colleagues at several centers in the United States. They presented the results of the interim analysis as part of a media briefing at the 28th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Philadelphia.

TRCs are derived from a small amount of bone marrow tissue and cultured in a closed, computer-controlled system for 12 days. The cultured cells are then implanted into the patient during open surgery.

For more information:

• Aastrom Biosciences Inc. Web site: www.aastrom.com.