Aastrom Biosciences reports interim data from long bone non-union fracture clinical trial

19-Sep-2006

Aastrom Biosciences, Inc. reported additional interim results from patients enrolled in its U.S. Phase I/II multi-center clinical trial evaluating Tissue Repair Cells (TRCs) in the treatment of recalcitrant long bone non-union fractures. Of the 36 patients enrolled in the FDA-approved trial, interim results were reported on 23 patients, including 12 patients who completed the total trial observation period of 12 months by August 2006. Of the 12 patients who have completed the one year follow-up period, 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, 6 out of 7 patients have returned to weight bearing mobility by 6 months. In the second sub-group, 8 out of 8 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% of the 23 patients by 3 months, and in 96% of these patients by 6 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.

https://www.bionity.com/en/news/57989/aastrom-biosciences-reports-interim-data-from-long-bone-non-union-fracture-clinical-trial.html