Harvest Technologies has reported that a 60-patient clinical trial using the company's BMAC System to treat patients with non-reconstructible critical limb ischemia is now underway at Shri Ramachandra Medical Center, a Harvard Medical international-associated institution based in Chennai, India.
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This study is designed to treat patients suffering from advanced thromboangitis obliterans, commonly referred to as Buerger’s disease. The condition of patients who are being enrolled in this study is said to be so severe that they have exhausted all surgical or endovascular options available and are facing amputation of the affected limb.
The study is being led by principal investigator Vijayaragavan, head of vascular surgery at Sri Ramachandra University. Harvest’s BMAC System is a point-of-care device for concentrating a patient’s own (autologous) bone marrow stem cells in approximately 15 minutes.
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