ThermoGenesis Corp. a leading supplier of innovative products and services that process and store adult stem cells, and TotipotentSC, a US company with a large India presence in medical devices, cellular therapy and clinical research management, announced they have received approval from Fortis Escorts’ (New Delhi) Independent Ethics Committee to proceed with a phase I b 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 US as a laboratory single use sterile (disposable) bone marrow concentration device. “We are pleased to manage this clinical trial in collaboration with ThermoGenesis. The trial will be conducted at the prestigious Escorts Heart Institute in New Delhi, which is part of the Fortis Healthcare network where TotipotentSC has a long term exclusive partnership for advancing the clinical adoption of adult cellular therapies,” said Ken Harris, chairman and CEO of MK Alliance, Inc. the parent company of TotipotentSC.

“We are looking forward to the initiation of enrollment in this clinical evaluation and are pleased to be collaborating with TotipotentSC as it shepherds the process in-country. The early experience with the Res-Q in orthopedic procedures has been positive and we believe it will prove to be a valuable tool in treating CLI patients. In addition, these types of clinical programs are an integral element of our strategy to increase awareness of and appreciation for the effectiveness of the device,” said J. Melville Engle, chairman and
chief executive officer of ThermoGenesis.

TotipotentSC, is a subsidiary of MK Alliance, Inc., a privately held company focused on the clinical scale up, manufacturing, and testing of cellular therapy devices. MK Alliance, Inc. also holds a majority ownership in TotipotentRX Corporation, which focuses on the scale-up, manufacturing and delivery of adult cellular therapies, having world class GMP facilities in Gurgaon, India.

ThermoGenesis Corp. is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These include: the BioArchive System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.

AutoXpress Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP MarrowXpress and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood. The MXP is used for the preparation of cell concentrates, including stem cells, from bone marrow aspirates in the laboratory setting. The Res-Q 60 BMC (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates.

The CryoSeal FS System, an automated device and companion sterile blood processing disposable, used to prepare fibrin sealants from plasma in about an hour. The CryoSeal FS System is approved in the US for liver resection surgeries. The CryoSeal FS System has received the CE-Mark which allows sales of the product throughout the European community.