Aastrom Biosciences, Inc. (Nasdaq:ASTMD), a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported results from a planned interim analysis of the company’s multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. 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 (e.g., 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.