Biomet Biologics, a subsidiary of Biomet and a manufacturer of orthopedic and biotechnology products, has enrolled the first subject into its multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial for critical limb ischemia (CLI).
Biomet said that the trial is being performed under an FDA-approved Investigational Device Exemption (IDE) and is intended to evaluate the safety and efficacy of the company’s MarrowStim PAD Kit to prevent or delay major amputation and/or death in subjects with CLI due to severe peripheral arterial disease (PAD).
The investigational treatment utilises autologous bone marrow aspirate, concentrated at the point of care with the MarrowStim PAD Kit, and delivered intramuscularly to the affected limb.
The initial subject was enrolled by Dr Michael Murphy, additional sites currently recruiting subjects include the Central Arkansas Veterans Healthcare System in Little Rock, and the University of Alabama at Birmingham.
Dr Murphy, assistant professor of vascular surgery at the Indiana University School of Medicine in Indianapolis, said: “This begins a national multicenter trial, unique in its design, that will evaluate the ability of a patient’s own stem cells to prevent leg amputation in end stage peripheral arterial disease. The results of this study will be a pivotal step in potentially providing a treatment for these patients who have no other options except for amputation.”
Stuart Kleopfer, president of Biomet Biologics, said: “We are pleased to reach the important milestone to provide a potential therapy for patients that would likely progress to amputation. This is another step forward in making autologous, minimally manipulated, point-of-care stem cell therapies available to the US patient population.”
Jeffrey Binder, president and CEO of Biomet, said: “We are proud to be working with these prestigious surgeons and institutions on a landmark study that has the potential to demonstrate an important advance in the treatment of a significant unmet clinical need. This program is an important element of Biomet’s emerging biologics platform.”