Updated with analyst comment, new stock price.
ORLANDO, Fla. ( TheStreet) -- A personalized cellular therapy developed by Aastrom Biosciences (ASTM) significantly restored damaged tissue in the legs of patients with arteries that are severely blocked, according to results from a mid-stage study presented Monday.Based on Monday's results, Aastrom will soon begin a phase III study to determine whether the cellular therapy, which is custom grown for patients from their own bone-marrow stem cells, can reduce amputations and prolong survival in patients with severe cases of critical limb ischemia (CLI). Patients with chronic CLI have obstructed arteries and reduced blood flow in the arms and legs, which can lead to open wounds and amputation in the most severe cases. CLI affects about 1 million people in the U.S. each year and leads to about 160,000 limb amputations each year. In the mid-stage study, 72 patients with CLI were treated with a one-time series of 20 injections in the legs and foot containing either Aastrom's cellular therapy, known as ixmyelocel-T, or a sham control. After one year of follow-up, treatment with Aastrom's cellular therapy demonstrated a statistically significant 62% reduction in the time to treatment failure compare to the sham control. Time to treatment failure is a composite endpoint that measures amputation, the onset of gangrene, wound size doubling and death. The cellular therapy outperformed the control for each of the individual components of the composite endpoint with the exception of mortality. A small, similar percentage of patients died in both the study arms. FDA will only approve a therapy for CLI if it can significantly reduce amputations because patients are at a much greater risk of dying following amputation. About 25% of patients die after undergoing a CLI-induced amputation. Aastrom's cellular therapy reduced the risk of amputation or death in the mid-stage study by 32% compared to the sham control, although the benefit was not statistically significant. "We were one event
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