A clinical trial was launched by researchers at University Hospitals Case Medical Center to evaluate the ability of a patient’s stem cells to prevent leg amputations in end stage peripheral artery disease (PAD).
The clinical trial, which is sponsored by Biomet Biologics, will enroll 152 patients who will be randomly assigned to receive either the investigational treatment involving the MarrowStim PAD Kit or a placebo control involving a sham procedure. Researchers will evaluate the trial’s primary endpoint of time to treatment failure, defined as major amputation or death, over a 1 year follow-up. Secondary endpoints, including rest pain, perfusion measurements, quality of life and safety, also will be evaluated for 1 year.
“This trial offers an opportunity to save a patient’s leg when there are no remaining options to improve blood supply,” Vik Kashyap, MD, division chief of vascular surgery at the University Hospitals Case Medical Center’s Harrington Heart & Vascular Institute and professor of surgery at Case Western Reserve University School of Medicine, Cleveland, stated.
To learn more about the clinical trial and to see qualifications for participation, visit www.clinicaltrialspotlight.com or call (877) 788-3972.