Zimmer Biomet touts successful stem cell therapy pilot program
Zimmer Biomet is seeing significant progress in developing a treatment for a disease that obstructs arteries by reducing blood flow to the extremities.
The success Zimmer Biomet is seeing with its trial treatment is a positive sign for the company as it develops its biologics pipeline, said David Nolan, group president for biologics, extremities, sports medicine, surgical, trauma, foot and ankle and office-based therapies.
“The positive data from our IDE (investigational device exemption) 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,” Nolan said in a company statement. “We look forward to completing the analysis of the full data set, unveiling the final results, and finalizing our regulatory submission to the FDA (U.S. Food and Drug Administration).”
The disease for which Zimmer Biomet is developing the treatment is called critical limb ischemlia, which affects about 1.5 million people nationally. It is the most severe form of peripheral arterial disease, causing severe pain, skin ulcers, sores and gangrene. Up to 30 percent of patients suffering from the disease do not qualify for conventional interventions to restore blood flow to the affected extremities. Therefore, about 40 percent of patients are at higher risk of amputation of the affected limb and about 20 percent are at higher risk of death, according to the company.
“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 institution,” said Dr. Michael Murphy, the lead investigator of the 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 Indiana University Center for Aortic Disease.
Zimmer Biomet’s trial utilizes stem cells from a patient’s bone marrow to prevent or delay amputation and/or death in patients suffering from critical limb ischemla.