"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," said David Nolan, Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle and Office Based Therapies for Zimmer Biomet. "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."
CLI, which affects an estimated 1.5 million patients in the U.S., is the most severe form of peripheral arterial disease whereby a severe obstruction of the arteries markedly reduces blood flow to the extremities (hands, feet and legs) causing severe pain, skin ulcers, sores or gangrene. Up to 30 percent of patients with CLI do not qualify for conventional interventions to restore blood flow (revascularization)1, and are therefore at higher risk of amputation of the affected limb (40 percent) or death (20 percent)2.
"There is an urgent need for alternatives to amputations in patients with advanced critical limb ischemia, nearly 30 percent of whom never fully recover and require chronic professional assistance at home or in an institution3," said Michael P. Murphy, M.D., the lead investigator of the MOBILE trial, and Associate Professor of Surgery, Associate Professor of Cellular and Integrative Physiology – Clinical, Director of the Vascular and Cardiac Center for Adult Stem Cell Therapy, and Director of the IU Center for Aortic Disease at the Indiana University School of Medicine in Indianapolis.
MOBILE is a prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of cBMA, injected intramuscularly into the affected limb, in preventing or delaying major amputation and/or death in patients with CLI who are unsuitable for revascularization. The primary efficacy endpoint of the study is Amputation Free Survival (AFS), time to major amputation and/or all cause mortality, at 1 year.
1Fadini GP, et al. Autologous stem cell therapy for peripheral arterial disease meta-analysis and systematic review of the literature. Atherosclerosis. 2010 Mar;209(1):10-7.
2TASC Working Group. Management of Peripheral Arterial Disease. J Vasc Surg 2000; 31:S20-S34
3Gupta SK, et al. Cost Factors in Limb-threatening Ischaemia due to Infrainguinal Arteriosclerosis. Eur J Vasc Surg 1988; 2 (3):151-4