PLYMOUTH, Mass., Nov. 9 /PRNewswire/ -- Harvest Technologies Corp. (www.harvesttech.com) announced today that the company sponsored 48-patient IDE clinical trial conducted at seven sites in the U.S. and one site in India using the company's Bone Marrow Aspiration Concentrate (BMAC) System to treat patients with non-reconstructable Critical Limb Ischemia (CLI) has completed enrollment. Mark D. Iafrati, M.D. Chief of Vascular Surgery at Tufts Medical Center in Boston, directed the study. "This study was unique in the high quality of the clinical investigators with each site being a center of excellence. Thus these patients deemed to have no conventional reconstruction possibility had truly exhausted current options. The BMAC procedure is easier to perform, quicker, less expensive, and less traumatic to our patients than most current treatments. If the results of this feasibility study demonstrate tangible benefits, this could herald a tremendous advance in how we treat patients with peripheral vascular disease." The study design calls for preliminary data analysis after the last subject has completed the 12-week follow-up visit. The company anticipates that these results should be available by the end of February.
Autologous cell therapy has been studied as an innovative treatment option for CLI, however; previously published studies did not use a rapid, point of care method for processing the cells therefore making widespread adoption of the therapy problematic. The Harvest trial utilized the BMAC system, which processes the cells in 15 minutes in the operating room. A unique feature of the trial was that it compared the relative effectiveness of the BMAC to a control injection of a placebo. Neither the trial subjects nor the investigators know which material was being injected. Thirty-two of the subjects received the BMAC composition by injection and sixteen received the placebo injection.
"We are particularly pleased that this study is now fully enrolled and by the very promising results shown with the Indian data analysis," said Gary D. Tureski, President of Harvest Technologies. "When combined with our other studies in Germany and the Czech Republic, this study should provide one more step in demonstrating the potential for Harvest's BMAC System to be an effective treatment for Chronic Limb Ischemia regardless of the underlying cause."
Harvest Technologies Corp.