Banner Heart Hospital currently is recruiting individuals to participate in a clinical trial, unique in its design, which will evaluate the use of a patient’s own stem cells in preventing leg amputations and improving circulation for people suffering from end-stage peripheral arterial disease (PAD).
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 supplying blood to the limbs.
The clinical trial will test the safety and effectiveness of the MarrowStim PAD Kit, an investigational treatment strategy designed to improve blood flow in legs with blocked arteries by attempting to create new blood vessels. This involves extracting stem cells from bone marrow and delivering them into the leg through multiple injections.
Because of the location and extent of the blockages in certain individuals, standard treatments will not improve blood flow to the leg, and amputation is the only alternative. Those treatments could include 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).
The trial sponsor, Biomet Biologics, recently completed a first-phase study of 30 subjects to evaluate the safety of autologous concentrated bone marrow aspirate for critical limb ischemia.
The results of this study were used to advance the company’s MarrowStim concentration technology into the pivotal Investigational Device Exemption trial described here. 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 PAD Kit (75 percent chance), or a placebo control involving a sham procedure (25 percent chance).
The trial’s primary end point of time to treatment failure, defined as major amputation or death, will be evaluated over a one-year follow-up period. Secondary end points, including rest pain, perfusion measurements, quality of life and safety, also will be evaluated for one year.
Only those patients meeting the pre-defined approved inclusion/exclusion criteria are eligible for this clinical trial. To learn more, and to see the qualifications for participation, visit www.clinicaltrialspotlight.com, or call toll-free at (877) 788-3972.