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Harvest Technologies Announces Trial Results in its India Study Using BMAC to Treat Patients With Non-Reconstructable Critical Limb Ischemia
Date:12/1/2009

of the therapy problematic. The Harvest trial, which enrolled the largest number of subjects of any study to date, utilized the BMAC system to process bone marrow aspirated from the patient in order to produce a highly concentrated composition of multipotent nucleated cells. The BMAC system is unique in that it can produce this cellular composition in 15 minutes within the operating room. A unique feature of the trial was to compare the relative effectiveness of two different delivery methods. Thirty of the subjects received the BMAC composition by injection and thirty received the same amount of BMAC but half of the volume by injection and the remaining half by infusion into a major artery.

The data from the 60 subjects was analyzed by an independent Contract Research Organization (Ecron Acunova, Bangalore, INDIA). The Ecron Acunova report showed that weeks 12 post treatment amputation free survival for the treated population was 90%. In addition, there was a statistically significant reduction in the subject's pain perception, increase in pain free walking distance, maximum walking distance, various perfusion measures including Regional Perfusion Index, as well as a significant improvement in the Quality of Life assessment (RAND-36 scores).

Another significant outcome, not shown in other studies, was the effect of the Harvest cell composition on the severity of the disease. CLI is a progressively degenerative disease with increasing serious in the disease being categorized by a classification system known as the Rutherford system; Rutherford classification progresses from 1 (least serious) to 6 (most serious with limb amputation imminent). All the 60 study patients were classified as either Rutherford class 4 or 5 (78% were class 5) and 12 weeks after treatment the treated cohort showed a mean reduction of one Rutherford class. "This is a truly extraordinary result," said Prof. Vijayaraghaven, "and if sustained through the end of the stu
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SOURCE Harvest Technologies Corp.
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