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Harvest Technologies Announces Interim Study Results From Critical Limb Ischemia Trial in Chennai India
Date:4/1/2009

equally into two treatment groups. Group 1 received forty (40) 1 mL intramuscular injections in the ischemic regions below the knee and Group 2 received twenty (20) 1 mL intramuscular injections below the knee and an intra-arterial infusion of 20 mL down the open SFA into the lower leg.

The interim evaluation of these patients conducted at 12 weeks showed convincing evidence that the treatment had significant clinical effect. The most important finding was that 87.5% of patients were able to save their legs. Other major endpoints also showed significance improvement. Quality of Life assessment (Rand-36 questionnaire) and individual perception of pain showed statistically significant improvement (p=0.0009 and 0.0001 respectively). There was 100% reduction in the use of pain medications. Limb perfusion, as measured by TcPO2 and ABI also showed statistically significant improvement (p=0.0001 and 0.0003 respectively). 33% of the patients had serious ulcers and 90% of these showed 90% or better wound closure in 26 weeks. There were no adverse events associated with the treatment. Harvest and its agent in India are hopeful that this data along with data generated in Europe will aid in obtaining the necessary clearances for the marketing the Harvest BMAC System for the treatment of CLI in India before the end of this calendar year.

Published studies in this area have used complicated methods to process and concentrate adult stem cells from a patient's bone marrow. The SmartPrep System is the first to offer clinicians a simple, easy point-of-care method to prepare a concentration of stem and precursor cells from a small aspirate of autologous bone marrow in just 15 minutes. Until now, it has been difficult to process and concentrate a clinically significant dose of adult stem cells from a patient's bone marrow at the point of care.

In Harvest's European studies, injected autologous adult s
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SOURCE Harvest Technologies Corp.
Copyright©2009 PR Newswire.
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