Results Published From RESTORE-CLI Phase IIb Clinical Trial
April 5, 2012—Aastrom Biosciences, Inc. (Ann Arbor, MI), announced that final results from the company's RESTORE-CLI phase IIb clinical trial for ixmyelocel-T were published by Richard J. Powell, MD, et al in Molecular Therapy, the journal of the American Society of Gene & Cell Therapy. The phase IIb 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. The subgroup of patients with wounds at baseline demonstrated an improvement in amputation-free survival. Ixmyelocel-T is an expanded, bone marrow-derived cellular therapy.
According to the company, the RESTORE-CLI study was a randomized, double blind, phase IIb clinical trial comparing the efficacy and safety of ixmyelocel-T to placebo. Patients received a one-time treatment of ixmyelocel-T via 20 intramuscular injections in the treated leg. The patients were followed for 12 months. The results also showed no major safety issues associated with treatment with ixmyelocel-T. Aastrom first announced the phase 2b results in June 2011, which was reported in Endovascular Today.
“These results clearly suggest that ixmyelocel-T has the potential to be a promising treatment option in patients with CLI who are not eligible for revascularization. This study represents an important advance in research related to regenerative medicine and the treatment of CLI patients,” commented Dr. Powell, a Co-Principal Investigator of the trial.
The company advised that efficacy assessments in the study 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.
The investigators found that 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 = .0032). A post hoc analysis of the subgroup of 45 patients with wounds at baseline resulted in a 77% risk reduction in time to first occurrence of treatment failure (P = .0002) and a positive trend in the phase III endpoint of amputation-free survival (61% risk reduction; P = .0915).
Based on these results, the company recently initiated the phase III REVIVE clinical trial at 80 treatment centers across the United States. REVIVE is an efficacy and safety study of ixmyelocel-T in patients with CLI. More information on the pivotal REVIVE phase III clinical trial is available at www.revivecli.com.