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Harvest Technologies Announces Completion of Patient Enrollment in its 60 Patient Clinical Trial in India Using Autologous Adult Stem Cells to Treat Patients With Non-Reconstructable Critical Limb Ischemia
Date:7/9/2009

PLYMOUTH, Mass., July 9 /PRNewswire/ -- Harvest Technologies Corp. (www.harvesttech.com) announced today that the company sponsored 60-patient clinical trial conducted at Sri Ramachandra Medical Center in Chennai, India using the company's BMAC System to treat patients with non-reconstructable Critical Limb Ischemia (CLI) has completed enrollment. Sri Ramachandra Medical Center is a Harvard Medical international-associated institution based in Chennai, India and one of the largest private healthcare facilities in South Asia. The study was directed by Prof. K. S. Vijayaragavan, Chief of Vascular Surgery at Sri Ramachandra University and met all regulatory approvals imposed by the Drug Controller of India and the Ethics Committee of Sri Ramachandra University, Chennai, India.

Critical limb ischemia is a persistent and relentless problem, which severely impairs the patient functional status and quality of life, and is associated with an increased cardiovascular mortality and morbidity. Prognosis of critical limb ischemia is poor and no effective treatments have been established in patients who are not amenable for the traditional revascularization therapies such as angioplasty and bypass procedures. Hence these patients have no option other than undergoing amputation or limb loss. In India a significant percentage of these patients with peripheral vascular disease are between the ages of 40 to 50. They suffer from ThromboAngitis Obliterans, which is predominant in young smokers. They have severe pain and limb loss is significant because revascularization chances are very low in these patients. Most of them end up in major amputation, lose their job and become dependant on their family to look after them.

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
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SOURCE Harvest Technologies Corp.
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