According to the interim analysis the safety profile was similar between the treatment and placebo arms. Based on a composite efficacy endpoint assessing time to treatment failure (including major amputations, wound size and gangrene), Aastrom’s autologous vascular repair cells (VRCs) were more effective than placebo (P<0.05).
Other clinically meaningful endpoints (eg, major amputation rate, complete wound closure) approached but did not reach statistical significance at interim analysis. Forty-six critical limb ischemia (CLI) patients who had at least 6-month follow up, including 33 patients with 12-month follow up, contributed to the interim analysis.
Aastrom’s Restore-CLI trial is the largest blinded, randomized cell therapy study currently being conducted for CLI. The interim analysis was planned to assess performance of the cell therapy and to help plan further studies. Based on the interim findings, Aastrom will conclude enrollment of new patients in order to complete the study as soon as possible, and begin planning and discussions with the FDA for pivotal clinical trials with VRCs.
Anthony Comerota, director of the Jobst Vascular Center in Ohio, said: “These encouraging data have demonstrated an excellent safety profile and indicate that Aastrom’s autologous cellular therapy could be an important addition to what is now a limited range of treatment options for patients with CLI.”
Tim Mayleben, president and CEO of Aastrom, said: “Based on these results, we can now move ahead with plans to advance this program into Phase 3 clinical testing. We look forward to presentation of the full data at an appropriate medical meeting and initiating the next phase of testing as soon as possible.”