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. 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.
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 three months, and in 96% of these patients by six months.
All 23 patients had 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. Ten 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.
This announcement follows positive interim data presented earlier this year. The presented results from the early clinical trial demonstrated bone healing after TRC therapy in all of the first seven patients and they returned to weight bearing mobility by six months.