06.10.11
Biomet Inc. and its subsidiary, Biomet Biologics, are reporting positive results from a Phase 1 safety trial for autologous concentrated bone marrow aspirate (BMA) therapy for treatment of critical limb ischemia. The trial used the company’s MarrowStim device for point-of-care concentration of the autologous BMA.
“We are pleased to reach this important milestone for potential therapy for patients who would likely progress to amputation,” said Joel Higgins, vice president and general manager 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.”
The study evaluated safety in 29 “no-option” patients with critical limb ischemia who were at risk for major amputation due to severe peripheral artery disease. The following results were reported in the June issue of the Journal of Vascular Surgery: no procedure-related deaths; two procedure-related serious adverse events not related to the MarrowStim device; an 8.63 percent one-year amputation-free survival rate; an improvement in rest pain, quality of life and perfusion measures at twelve weeks post-treatment; and an overall average MarrowStim procedure time of less than two hours.
“The results of this study are a crucial step in potentially providing alternative treatment for those patients who have no options other than amputation,” said Michael P. Murphy, M.D., professor of vascular surgery and clinical director of the Vascular and Cardiac Center for Adult Stem Cell Therapy at Indiana University School of Medicine in Indianapolis, Ind. Murphy led the study, which was performed under a U.S. Food and Drug Administration (FDA)-approved Investigational New Drug Application (IDE).
Based on these results, Biomet Biologics began planning a multicenter, prospective, randomized, double-blind, placebo-controlled trial under an FDA-approved IDE. The trial will evaluate the safety and efficacy of autologous concentrated bone marrow aspirate therapy to prevent or delay major amputation in 152 subjects with critical limb ischemia. Researchers are expected to finish collecting one-year data in May 2014.
Biomet is headquartered in Warsaw, Ind
“We are pleased to reach this important milestone for potential therapy for patients who would likely progress to amputation,” said Joel Higgins, vice president and general manager 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.”
The study evaluated safety in 29 “no-option” patients with critical limb ischemia who were at risk for major amputation due to severe peripheral artery disease. The following results were reported in the June issue of the Journal of Vascular Surgery: no procedure-related deaths; two procedure-related serious adverse events not related to the MarrowStim device; an 8.63 percent one-year amputation-free survival rate; an improvement in rest pain, quality of life and perfusion measures at twelve weeks post-treatment; and an overall average MarrowStim procedure time of less than two hours.
“The results of this study are a crucial step in potentially providing alternative treatment for those patients who have no options other than amputation,” said Michael P. Murphy, M.D., professor of vascular surgery and clinical director of the Vascular and Cardiac Center for Adult Stem Cell Therapy at Indiana University School of Medicine in Indianapolis, Ind. Murphy led the study, which was performed under a U.S. Food and Drug Administration (FDA)-approved Investigational New Drug Application (IDE).
Based on these results, Biomet Biologics began planning a multicenter, prospective, randomized, double-blind, placebo-controlled trial under an FDA-approved IDE. The trial will evaluate the safety and efficacy of autologous concentrated bone marrow aspirate therapy to prevent or delay major amputation in 152 subjects with critical limb ischemia. Researchers are expected to finish collecting one-year data in May 2014.
Biomet is headquartered in Warsaw, Ind