Cytori Therapeutics is a company developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to cardiovascular disease and repair soft tissue defects. The company's therapies are made available through its proprietary device, the Cellution System, which automates the extraction and preparation of clinical grade ADRCs at the point-of-care.
The company's scientific data suggests ADRCs improve blood flow, moderate the immune response, and keep tissue at risk of dying alive. Additionally, positive results have been reported from Europe with regards to the treatment of ischemic heart failure using ADRCs. Cytori therefore believes that these cells can be applied across multiple ischemic conditions.
The company today announced that a 40-patient, multi-center investigator-sponsored and funded clinical study in Japan using the Cellution System has been approved under the Ministry of Health, Labor, and Welfare Guidelines on Clinical Research Using Human Stem Cells. The principal investigator in the study is Toyoaki Murohara, M.D., Ph.D., Professor and Chairman, Department of Cardiology at the primary trial center, Nagoya University Graduate School of Medicine. Two other Japanese sites will also participate in the study.
The study will enroll patients with peripheral artery disease (PAD), Burger's disease, or with severe limb ischemia caused by connective tissue disease. PAD is a common circulatory problem in which narrowed arteries reduce blood flow to the limbs. 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 exams at one week and at one, three, and six months with primary endpoints being the safety of the treatment and limb salvage rates as compared to conventional treatment.
For further information about Cytori Therapeutics and its Cellution System family of products, please visit the company's website at cytori.com
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