Jun 5 2010
Biomet, a global leader in the manufacture of orthopedic and biotechnology products, announced today that its subsidiary, Biomet Biologics, has enrolled the first subject into its multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial for critical limb ischemia (CLI). 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™ P.A.D. Kit to prevent or delay major amputation and/or death in subjects with CLI due to severe peripheral arterial disease (P.A.D.). The investigational treatment utilizes autologous bone marrow aspirate, concentrated at the point of care with the MarrowStim™ P.A.D. Kit, and delivered intramuscularly to the affected limb.
“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.”
The initial subject was enrolled by Dr. Michael P. Murphy, Assistant Professor of Vascular Surgery at the Indiana University School of Medicine in Indianapolis. Additional sites currently recruiting subjects include the Central Arkansas Veterans Healthcare System in Little Rock, and the University of Alabama at Birmingham.
"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," said Dr. Murphy. "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."
For patients with CLI, revascularization procedures such as surgical bypass or percutaneous angioplasty are currently the only option to restore perfusion and maintain limb viability. For CLI patients who are non-candidates for revascularization (i.e., extensive occlusive disease, failed previous bypass, insufficient autologous vein to create a viable graft), the remaining treatment option is amputation. It is estimated that over 160,000 amputations are performed in the United States each year. The number of CLI patients who will not be candidates for revascularization continues to rise as the population ages and the incidence of diabetes and other vascular risk factors increase. For CLI patients who are considered unreconstructable, the amputation and mortality rates at six months approach 40% and 20%, respectively. Furthermore, nearly 30% of patients who undergo below-knee amputation will fail rehabilitation and require chronic institutional care or professional assistance at home.
"We are pleased to reach this important milestone to provide a potential therapy for patients that would likely progress to amputation," said Stuart Kleopfer, President of Biomet Biologics. "This is another step forward in making autologous, minimally manipulated, point-of-care stem cell therapies available to the U.S. patient population."
Jeffrey Binder, President and CEO of Biomet, stated, ""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."
Biomet Biologics recently completed a Phase I study of 30 subjects to evaluate the safety of autologous concentrated bone marrow aspirate for critical limb ischemia. The results of this Phase I study were used to advance the company's MarrowStim™ concentration technology into the FDA-approved, pivotal IDE trial described here. Overall, the trial will enroll 152 subjects at up to 20 investigational sites. Subjects will be randomized to receive either the investigational treatment involving the MarrowStim™ P.A.D. Kit, or a placebo control involving a sham procedure. The trial's primary end point of time to treatment failure, defined as major amputation or death, will be evaluated over a one-year follow-up period. Secondary end points, including rest pain, perfusion measurements, quality of life, and safety, will also be evaluated for one year. Completion of subject enrollment is estimated for September, 2011 and completion of one-year data collection for September, 2012.
SOURCE Biomet, Inc.
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