Aastrom Biosciences, Inc. Announces Final Results From RESTORE-CLI Phase 2b Clinical Trial For Ixmyelocel-T

Aastrom Biosciences, Inc. 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 Phase 2b clinical results demonstrated that treatment with ixmyelocel-T improved time to treatment failure in patients with critical limb ischemia (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. In the study, efficacy assessments included time to first occurrence of treatment failure, defined as major amputation, all-cause mortality, doubling of total wound surface area from baseline, or de novo gangrene. A total of 48 patients were treated with ixmyelocel-T and 24 received a placebo. Adverse event rates in both groups were similar. Patients in the treatment arm showed a 62% reduction in risk relative to placebo in the primary efficacy endpoint of time to first occurrence of treatment failure (p =0.0032).