PLYMOUTH, Mass. (PRWEB) October 28, 2008
The Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to Harvest Technologies to conduct a randomized, controlled, double-blind, multicenter clinical trial using the Company's BMAC System to prepare a composition of bone marrow stem cells to treat patients with Critical Limb Ischemia (CLI). This "feasibility trial" will enroll a total of 48 subjects. Subjects who enroll in this study have exhausted all surgical and procedural options and are at extreme risk for major amputation. The BMAC System is a point-of-care device for concentrating a patient's own (autologous) bone marrow stem cells in approximately 15 minutes at the bedside. The clinical study design provides for injecting these cells into the affected limb to reduce the potential for limb amputation. It also will offer data with respect to the safety of this procedure.
This U.S. clinical study is being led by Principal Investigator Mark D. Iafrati, M.D., Chief of Vascular Surgery at Tufts Medical Center, Boston. In addition, the CLI Study is also enrolling subjects at: Roper St. Francis Healthcare, Charleston, S.C.; Methodist Hospital, Houston; University of South Florida Health, Tampa, Fla.; Maimonides Medical Center, Brooklyn, N.Y.; and Vascular Associates of Albany, Albany, N.Y.
Published studies in this area have used complicated methods to process and concentrate adult stem cells from a patient's bone marrow. The BMAC System is the first to offer clinicians a simple, easy point-of-care method to prepare a concentration of stem and precursor cells from a small aspirate of autologous bone marrow in just 15 minutes.
Harvest Technologies is a privately held company based in Plymouth, Mass.