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October 11, 2012
08:02 EDTCYTXCytori Therapeutics's U.S. cell therapy heart failure trial treats first patient
Cytori Therapeutics initiated the FDA approved ATHENA clinical trial to investigate Cytori’s cell therapy in patients who suffer from a severe form of refractory (untreatable) heart failure due to chronic myocardial ischemia. Cytori’s cell therapy is based on a patient’s own adipose-derived stem and regenerative cells processed by the company’s proprietary Celution System technology, making this the first FDA approved trial in the U.S. to evaluate ADRCs for cardiovascular disease. This first patient has undergone a seven day follow-up assessment. ATHENA is a device-based, multi-center, prospective, randomized, double-blind PMA/IDE safety and feasibility (Phase I/II) trial that will enroll 45 patients in six centers in the U.S
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