Cytori Therapeutics (NASDAQ: CYTX) today announced
that a 40-patient, multi-center investigator-sponsored and funded clinical study in Japan using the Celution® System has been approved under the Ministry of Health, Labor and Welfare (MHLW) Guidelines on Clinical Research Using Human Stem Cells.
The study will investigate the use of patients’ own adipose-derived stem and regenerative cells (ADRCs) processed by the Celution® System for peripheral artery disease (PAD) or arteriosclerosis obliterans (AO). PAD or AO are common circulatory problems in which narrowed arteries reduce blood flow to the limbs. The principal investigator will be Toyoaki Murohara, M.D., Ph.D., Professor and Chairman, Department of Cardiology at the primary trial center, Nagoya University Graduate School of Medicine. The trial will include two additional Japanese sites.
“It has been reported by many researchers domestically (Japan) and overseas that transplantation of ADRCs stimulates vascularization of an ischemic area,” said Dr. Murohara. “Specifically, positive clinical results were reported with regards to the treatment for ischemic heart failure in Europe using ADRCs. Although Japan has lagged far behind in this field, I believe that approval by MHLW under the new clinical research guidelines to study ADRCs for limb ischemia is a big step for medical care of vascularization therapy in Japan.”
This multi-center, single arm study will enroll up to 40 patients with peripheral artery disease, Burger’s disease, or with severe limb ischemia caused by connective tissue disease. Each patient will receive an injection of their own ADRCs into the skeletal muscle at the affected area on the limb. Patients will undergo follow-up examinations at one week and at one, three and six months with primary endpoints of safety and limb salvage rate as compared to conventional treatment.
Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® system product family.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, inherent risk and uncertainty in the protection of intellectual property rights, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, including its annual report on Form 10-K for the year ended December 31, 2011. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.