The trial, performed under an FDA-approved investigational new drug (IND) application, used the company’s MarrowStim device for point-of-care concentration of the autologous BMA for the treatment.
The trial was performed at the Indiana University School of Medicine in Indianapolis and was led by Michael Murphy, clinical director of the Vascular and Cardiac Center for Adult Stem Cell Therapy and assistant professor of Vascular Surgery.
The trial has reported one-year amputation-free survival rate of 86.3%; improvement in rest pain, quality of life, and perfusion measures at twelve-weeks post-treatment; and overall average MarrowStim procedure time (i.e., aspiration, concentration, delivery) of less than two hours.
Upon completion of the Phase I safety study, Biomet Biologics advanced the company’s MarrowStim concentration technology into a multicenter, prospective, randomized, double-blind, placebo-controlled trial under an FDA-approved investigational device exemption (IDE).
The pivotal trial will evaluate the safety and efficacy of autologous concentrated BMA to prevent or delay major amputation and/or death in subjects with CLI.
The trial will enroll a total of 152 subjects and is currently ongoing at 14 investigational sites, with additional sites planned.
Subject enrollment began in June 2010 and is estimated for completion in May 2013, with completion of one-year data collection in May 2014.
