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 Lim...(method for processing the cells therefor...)

Date:7/9/2009

method for processing the cells therefore making widespread adoption of the therapy problematic. The Harvest trial utilized the BMAC system, which can process the cells 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.

Prof. K. S. Vijayaragavan presented interim results on the first thirty patients treated with at least twelve weeks follow up at the Cardiovascular Research Foundation meeting on January 15, 2009 in New York City. He showed a limb salvage rate of 87.5% and significant improvement in reduction of pain, improvement in perfusion measures and in quality of life. Results on the total study population will be presented in October at the Indian Society of Vascular Surgery where the therapy will be considered for designation as a standard of care therapy.

Dr. Amit Patel, Associate Professor of Surgery and Director of Cardiovascular and Regenerative Medicine at the University of Utah School of Medicine, presented additional analysis of the interim data at the International Society for Cellular Therapy in May of 2009. Specifically, he showed data that delivering the BMAC cellular composition had a positive effect on healing wounds and that both methods of delivery showed similar results. His presentation concluded: "Based on these results, this bone marrow composition may be considered safe and has shown potential to reduce amputation rates and improve the quality of life for no-option CLI patients. This study has also shown that both the methods of delivery are equally effective and safe."

"We are particularly pleased that this study is now fully enrolled and by the very promising results shown
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SOURCE Harvest Technologies Corp. Copyright©2009 PR Newswire. All rights reserved

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