RANCHO CORDOVA, Calif., May 11, 2016 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced the results of six late-stage critical limb ischemia (CLI) patients treated with its SurgWerks™-CLI system on a compassionate use basis. In a six-month follow-up of the patients, they reported favorable outcomes in lifestyle and pain reduction. The procedures were conducted by Dr. Suhail Bukhari of the Fortis Escorts Heart Institute and Research Center in New Delhi, India.
“Following completion of Cesca’s phase I/II feasibility study for critical limb ischemia in 2013, which did not manifest any device-related adverse events, I diagnosed six patients in desperate need of a solution for CLI,” said Dr. Bukhari. “Considering all other non-surgical and surgical options, I was compelled, as a physician and caregiver, to provide medical assistance with SurgWerks with the consent of the patients and in compliance with local regulations.”
At the six-month follow-up, Dr. Bukhari observed that the patients’ pain scores fell from an average of 7.6 before treatment to 0.67, with four of the six patients reporting no pain. Foot ulcers and open wounds appearing on five of the six original patients healed, while five of the six were amputation-free after six months. A video outlining these compassionate use cases at Fortis Escorts Heart Institute and patients’ comments can be viewed on Cesca’s website at www.cescatherapeutics.com.
CLI is a late-stage form of peripheral artery disease that can result in severe non-healing ulcers and potential loss of limb due to the lack of blood circulation. While surgical and non-surgical options continue to improve, approximately 70,000 patients undergo major limb amputation as a result of CLI each year in the U.S. alone. A further 135,000 patients undergo minor amputation that results in a significant decrease in quality of life.
The company has received FDA approval for a pivotal trial for CLI using its SurgWerks™ System, and is preparing to submit an IDE supplement for review. The point-of-care stem cell therapy kit provides an integrated toolkit and protocol for using a patient’s own bone marrow cells to treat the affected limb in a 2-hour treatment in the hospital treatment suite. The company’s treatment approach is differentiated from many other companies’ within this space by providing solutions/controls for each step of the treatment, including cell harvesting, processing, analysis and delivery.
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics. These include:
- The SurgWerks™ System (in development) - a proprietary system comprised of the SurgWerks Processing Platform, including devices and analytics, and indication-specific SurgWerks Procedure Kits for use in regenerative stem cell therapy at the point-of-care for vascular and orthopedic diseases.
- The CellWerks™ System (in development) - a proprietary cell processing system with associated analytics for intra-laboratory preparation of adult stem cells from bone marrow or blood.
- The AutoXpress® System (AXP®) - a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.
- The MarrowXpress™ System (MXP™) - a derivative product of the AXP and its accompanying sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.
- The BioArchive® System - an automated cryogenic device used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.
- Manual bag sets for use in the processing and cryogenic storage of cord blood.
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Source:Cesca Therapeutics Inc.