Aastrom Biosciences Inc. (ASTM) announced that final results from the company's RESTORE-CLI Phase 2b clinical trial for ixmyelocel-T were published in the peer-reviewed journal Molecular Therapy.
The company stated that the Phase 2b clinical results demonstrated that treatment with ixmyelocel-T improved time to treatment failure in patients with critical limb ischemia or CLI compared to the control group, and in the subgroup of patients with wounds at baseline demonstrated an improvement in amputation free survival.
The RESTORE-CLI study was a randomized double blind Phase 2b clinical trial comparing the efficacy and safety of ixmyelocel-T to placebo. Patients received a one-time treatment of ixmyelocel-T of 20 intramuscular injections in the treated leg and were followed for 12 months. The results also showed no major safety issues associated with treatment with ixmyelocel-T.
CLI is the most severe form of peripheral arterial disease caused by chronic inflammatory processes associated with atherosclerosis that result in markedly reduced blood flow to the legs, feet and hands.
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