Harvest Technologies Announces Interim Study Results From Critical Limb Ischemia Trial in Chennai India |
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By: Harvest Technologies Corp. Posted: 2009-04-01 07:41:57 |
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Harvest Technologies Corp announced today that the interim study report was completed for the first thirty (30) patients in the clinical trial of patients suffering with non-reconstructable critical limb ischemia due to advanced thromboangitis obliterans, commonly referred to as Buerger's Disease.
The trial is being conducted at Sri Ramachandra University in Chennai India and is designed to evaluate the therapeutic effect of a composition of nucleated bone marrow cells prepared using the Harvest SmartPReP System. The study is being led by principal investigator Prof. K. S. Vijayraghavan, Head of Vascular Surgery. Harvest's SmartPReP System is a point-of-care device for concentrating a patient's own (autologous) bone marrow stem cells in approximately 15 minutes. Prof. Vijayraghavan stated, "This study has very important implications for treating this patient population, because they are young (average age 45) and have limited access to any revascularization options. The trial was the first of its kind to be approved by all regulatory bodies in India," and was conducted in accordance with the significant risk provision of the Investigational Device Exemptions Regulations (21 CFR Part 812); the Protection of Human Subjects Regulations, including Subpart B Informed Consent of Human Subjects (21 CFR Part50); the Institutional Review Board Regulations (21 CFR Part 56). Patients enrolled in the trial were treated with a composition of concentrated bone marrow nucleated cells, termed BMAC. A total of 240 mL of marrow aspirate was processed using the point of care SmartPReP System (Harvest Technologies, Plymouth, MA) to yield 40 mL of treating volume. The patients were divided 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 stem cell concentrates from bone marrow have shown promise in achieving tissue regeneration in vascular, orthopedic and cardiovascular disease. In the U.S., Harvest Technologies is sponsoring a multi-centered randomized controlled double-blind study evaluating the therapeutic effect of BMAC for treating patients with non-reconstructable CLI. Harvest Technologies is a privately held company based in Plymouth, Mass. Contact: P. Kevin Benoit, VP/General Manager, Strategic Business Development: 508-732-7528 |
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