(NASDAQ: CYTX) today announced
two independent investigator-sponsored and funded cell therapy clinical studies in Japan have been approved by the Ministry of Health, Labor and Welfare under the Guidelines on Clinical Research Using Human Stem Cells. One study will investigate the use of Cytori’s cell therapy as a treatment for ischemic heart failure and the other as a treatment for cirrhosis of the liver. The studies will be performed by Shuichi Kaneko, M.D., Ph.D., Professor and Chairman of Departments of Gastroenterology, and Disease Control and Hemostasis, Graduate School of Medicine at Kanazawa University Hospital School of Medicine.
In each study, patients will receive an injection of Cytori’s cell therapy, which consists of their own adipose-derived stem and regenerative cells (ADRCs) processed at the point-of-care using the Cytori’s proprietary and automated Celution® System. The ischemic heart failure study will enroll patients with low left ventricular function due to a prior heart attack and the ADRCs will be delivered through the coronary artery. In the study of patients with cirrhosis of the liver, the ADRCs will be delivered through the hepatic artery.
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.