Zimmer Biomet (NYSE:ZBH) touted data today from an investigational device exemption trial evaluating the use of autologous concentrated bone marrow aspirate for the treatment of critical limb ischemia. The stem cell study is the 1st pivotal trial of its kind to complete enrollment and a 1-year follow-up in a patient population that is ineligible for revascularization, the company said.
Warsaw, Ind.-based Zimmer Biomet’s trial is a prospective, randomized, double-blind study of stem cells injected intramuscularly into the affected limb to prevent or delay major amputation or death in patients with critical limb ischemia. The primary efficacy endpoint is the time to major amputation and all-cause mortality at 1 year.
Preliminary results from a partial data set found that treatment with concentrated bone marrow aspirate improved amputation-free survival compared to a placebo, while maintaining a safety profile similar to the placebo.
“We’re excited to announce positive progress on our investigational treatment for critical limb ischemia that anchors our emerging biologics pipeline and highlights the breadth of our innovative research and development capability,” president David Nolan said in prepared remarks. “The positive data from our IDE trial places Zimmer Biomet at the forefront of advancing our understanding of the clinical utility of autologous cell therapy, which is one of the most promising areas within biologics. We look forward to completing the analysis of the full data set, unveiling the final results, and finalizing our regulatory submission to the FDA.”
“There is an urgent need for alternatives to amputations in patients with advanced critical limb ischemia, nearly 30% of whom never fully recover and require chronic professional assistance at home or in an institution,” added lead investigator Dr. Michael Murphy of the Indiana University School of Medicine.