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.
Critical limb ischemia is a persistent and relentless disease, which severely impairs patients' functional status and quality of life, and is associated with an increased cardiovascular mortality and morbidity. The prognosis of critical limb ischemia is poor. Even when patients are candidates for current revascularization therapies such as angioplasty or bypass surgery, these therapies are commonly accompanied by significant morbidity and mortality risk. When patients are not candidates for conventional therapies as was the case in the patients enrolled in this clinical trial, the outcomes are uniformly poor. These patients are afflicted with intractable pain and a very high risk of limb loss and/or death.