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ThermoGenesis Corp. and TotipotentSC Receive Approval for Phase Ib Clinical Trial of Res-Q™ 60 BMC for Treatment of Critical Limb Ischemia
Date:1/26/2011

RANCHO CORDOVA, Calif., Jan. 26, 2011 /PRNewswire/ -- ThermoGenesis Corp. (Nasdaq: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, and TotipotentSC, a U.S. company with a large India presence in medical devices, cellular therapy and clinical research management, announced today they have received approval from Fortis Escorts' (New Delhi) Independent Ethics Committee to proceed with a Phase Ib clinical trial in patients suffering from Non-Reconstructable Critical Limb Ischemia (CLI) utilizing ThermoGenesis' Res-Q™ 60 BMC system.

CLI, an advanced stage of peripheral artery disease, is characterized by peripheral arterial obstruction resulting in a severe reduction in blood flow to the extremities (hands, feet and legs).  This chronic vascular disorder presents symptoms progressing from mild discomfort to severe rest pain, skin ulcers and major tissue death.  CLI may result in limb amputation if not properly treated.  CLI afflicts millions of patients globally, and has a significant impact in the Indian population.  As such, CLI is a heavy burden on the Indian healthcare system with an estimated 20 million patients suffering from various stages of the disease.

The objectives of the trial are to assess safety and efficacy of stem cells derived from autologous concentrated bone marrow prepared using the Res-Q system.  Specific primary endpoints include safety of the cell processing and delivery plus limb salvage rates in 15 patients suffering from the most advanced stage of peripheral artery disease.  Each enrolled patient will have been determined medically unsuitable for further traditional modalities of treatment.  

The Res-Q system is CE-Marked for Europe and is an exempt Class I device in the U.S. as a laboratory single use sterile (disposable) bone marrow concentrati
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SOURCE ThermoGenesis Corp.
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