Aastrom Biosciences (ASTM) Final Results from RESTORE-CLI P2b Clinical Trial for CLI
ASTM’s final results from the RESTORE-CLI P2b clinical trial for ixmyelocel-T were published in the peer-reviewed journal MolecularTherapy.
- The P2b 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 P2b clinical trial comparing the efficacy and safety of ixmyelocel-T to placebo. Patients received a 1 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;
- 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 and a positive trend in the P3 endpoint of amputation-free survival (61% risk reduction.
The Bottom Line: 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. ASTM has initiated the P3 REVIVE clinical trial at 80 treatment centers across the US.