AASTROM BIOSCIENCES ANNOUNCES DATA FROM BONE-HEALING TRIAL
Aastrom Biosciences has reported additional interim results from patients enrolled in its U.S. Phase I/II trial evaluating tissue-repair cells (TRCs) in the treatment of recalcitrant long-bone non-union fractures. Of the 36 patients enrolled in the trial, interim results were reported on 23 patients, including 12 patients who completed the total trial observation period of 12 months in August. Of those 12 patients, 10 showed bone bridging at the fracture site, indicating radiographic evidence of healing.
At this time, two subsets of patients totaling 15 have completed clinical examination surveys with their doctors. In the first sub-group, six out of seven patients have returned to weight-bearing mobility by six months. In the second sub-group, all eight patients have returned to weight-bearing mobility by 12 months.
Callus formation is the first sign of healing and return of blood flow. After being treated with Aastrom's TRC-based cell product, callus formation was observed in 78 percent of the 23 patients by three months, and in 96 percent of these patients by six months.
All 23 patients had atrophic non-union fractures of a long bone (leg or arm), which had failed to heal after prior standard of care bone grafting and surgical treatments, and consequently, were considered very difficult to treat; 10 of the patients had failed two to three prior treatments. Of the patients reported to date, 10 of the patients were smokers who have a particularly poor prognosis for healing.
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