Patients with severe peripheral arterial disease being recruited
Spectrum Health is participating in a clinical trial evaluating the use of a patient’s own stem cells in preventing leg amputations and improving circulation for people who suffer from end-stage peripheral arterial disease (PAD). Spectrum Health currently is the only health system in Michigan participating in this trial and is currently recruiting individuals from West Michigan.
PAD, a serious disease which affects about 8 million Americans, occurs when extra cholesterol and fat circulating in the blood collects on the walls of the arteries that supply blood to the limbs.
The clinical trial will test the safety and effectiveness of the MarrowStim™ P.A.D. Kit, a new investigational treatment strategy designed to improve blood flow in the legs by attempting to increase blood flow by enhancing the body’s own ability to grow new blood vessels, a process called angiogenesis. This involves extracting stem cells from bone marrow and delivering them into the leg through multiple injections.
About one in every 20 Americans over the age of 50 has PAD, a condition that raises the risk for heart attack and stroke, says study principal investigator Christopher Chambers, MD, PhD, a vascular surgeon with the Spectrum Health Medical Group. “Most patients with PAD can be treated with lifestyle changes, medicines, and endovascular or surgical procedures,” sayd Chambers. “However, despite advanced techniques and technology, about 10-20 percent of people with severe PAD do not respond to these measures and are at risk for lower limb major amputation. I’m hoping this new investigational technology will give these patients another option.”
Because of the location and extent of the blockages in certain individuals, standard treatments such as surgical bypass (insertion of a vein or synthetic graft to redirect blood flow around the blockage) and angioplasty (insertion of a balloon through the artery to open the blockage) will not improve blood flow to the leg, and amputation is the only alternative.
In the procedure, the patient’s own bone marrow will be concentrated in the investigative device, and then injected at several locations along the affected leg, in an attempt to improve blood flow.
Trial sponsor Biomet Biologics recently completed a first-phase study of 30 subjects to evaluate the safety of using bone marrow aspirate in this fashion. The results of that study were used to advance the company’s MarrowStim™ concentration technology into the current, FDA-approved, pivotal IDE trial.
Overall, the trial will enroll 152 subjects at up to 20 investigational sites in the United States. Subjects will be randomized to receive either the investigational treatment involving the MarrowStim™ P.A.D. Kit (75 percent chance), or a placebo control involving a sham procedure (25 percent chance). Patients will be regularly evaluated for a year after the procedure.
Only those patients meeting the pre-defined approved inclusion/exclusion criteria are eligible for this clinical trial. To learn more about this clinical trial and to see the qualifications for participation, visit www.clinicaltrialspotlight.com or call toll-free at 877-788-3972.