The U.S. biotech company Harvest Technologies has received Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA) to conduct the first randomized, double blind placebo controlled clinical trial in the U.S. in which autologous adult stem cells will be used to treat patients with end-stage critical limb ischemia (CLI).
CLI is the terminal stage of peripheral artery disease (PAD), for which the only treatment is usually amputation, which carries a high risk of mortality. Now, however, adult stem cells offer the possibility of a new form of treatment for CLI, by which the diseased tissue of the affected limb could be regenerated, thereby sparing the limb from amputation.
This “feasibility trial” will enroll 48 patients who are at extreme risk of amputation, having exhausted all surgical and procedural options and who will be treated with their own autologous (in which the donor and the recipient are the same person) adult stem cells derived from their own bone marrow and prepared with the company’s proprietary BMAC (Bone Marrow Aspirate Concentrate) System which is a point-of-care device that concentrates a patient’s own adult stem cells from their own bone marrow in approximately 15 minutes at the bedside. The stem cells will then be injected directly into the affected limb in an effort to induce angiogenesis (blood vessel formation) and thereby rescue the limb from the necessity of amputation.
Based in Plymouth, Massachusetts, Harvest Technologies is the first company to offer clinicians a simple and easy-to-use point-of-care method for concentrating and preparing stem and precursor cells from a small aspirate of autologous bone marrow in just 15 minutes through its BMAC bone graft applicators, which facilitate the premixing of bone graft materials with bone marrow aspirate concentrate. Unlike previous studies that have been conducted in which more complicated methods were used for processing and concetrating adult stem cells from a patient’s bone marrow, the BMAC graft delivery pack streamlines and expedites both the preparation and the ultimate delivery of the graft composite to the surgical site.
Harvest Technologies is also providing a patient-education website for individuals participating in the clinical trial, and their referring physicians, at www.CLIclinicalstudy.com, where information on the study and the science underlying it is now available. The clinical trial is being led by Principal Investigator Mark D. Iafrati, M.D., Chief of Vascular Surgery at Tufts Medical Center in Boston, and the CLI study is also enrolling subjects at participating locations in South Carolina, Houston, Florida, and New York.
