Cytori Therapeutics (NASDAQ: CYTX) announced the initiation of 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 (ADRCs) 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 was treated by co-principal investigator Timothy Henry, M.D., Director of Research, at the Minneapolis Heart Institute Foundation in September and has undergone a seven day follow-up assessment. More details on the ATHENA trial may be found at www.theathenatrial.com.
“Patients with refractory heart failure have no options except for heart transplant, for which there are few hearts available,” said Dr. Henry. “Cell therapy such as Cytori’s has the potential to delay, halt, or even reverse this progression. We believe this is accomplished by the cells’ ability to promote angiogenesis and regulate the immune response to help revive damaged tissue that is alive yet not necessarily contributing to its fullest capacity toward the pumping ability of the heart.”
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. Patients will be randomized to receive either Cytori’s cell therapy (n=30) or an inactive placebo injection (n=15). All trial participants will undergo a minor liposuction procedure to remove adipose tissue. The adipose tissue will then be processed at the point-of-care with Cytori’s proprietary system to separate and concentrate clinical-grade ADRCs. The treatment group will have a prescribed dose of the patient’s own ADRCs (0.4 million cells/kg body weight), which will then be injected into their damaged heart tissue using a minimally invasive catheter system.