Cytori Therapeutics, Inc. has reported top-line preliminary results, demonstrating that adipose-derived stem and regenerative cells from its proprietary Celution system was safe and improved heart function, in a chronic ischemia model, representing a severe form of coronary artery disease. The study was conducted by Emerson Perin, MD, Ph D, at Texas Heart Institute, in collaboration with Cytori. The full data and analysis of this study will be presented later this year.

In this blinded, randomized study, seven pigs received their own adipose stem and regenerative cells (treated) or a saline injection (control, six animals). Autologous adipose stem and regenerative cells were extracted and concentrated using the Celution System, Cytori's automated cell processing system. The cells were then delivered via the NOGA, mapping and delivery system directly into the ischemic sites. Thirty days following treatment, the cell treated group exhibited a 13 per cent (p = 0.03), absolute improvement in ejection fraction over the control group.

Ejection fraction is a common measure of the heart's pumping efficiency. Consistent with this functional improvement, heart structure was preserved as evidenced by a 37 per cent (p = 0.0001) thicker ventricular wall, in the cell treated groups, versus the control. Improved wall thickness leads to improved mechanical properties of the heart, which may slow deterioration of its pumping ability.

"This is the first report of adipose stem and regenerative cells, as a treatment for ischemic-related coronary artery disease, in a randomized large animal preclinical study," stated Dr Perin. "It was carefully designed to approximate as closely as possible a true clinical setting. The results showed that within the treated group there was significant improvement of key measurements of heart performance including ejection fraction and wall thickness as well as a corresponding decrease in the amount of scar tissue."

"This outcome is consistent with our prior preclinical cardiac data and demonstrates the exciting potential of this therapy to significantly improve the function of damaged hearts," stated Marc H. Hedrick, MD, President of Cytori Therapeutics. "These results also reveal to us valuable information, related to the design of our planned chronic ischemia clinical study in Europe."

Cytori's precise clinical study in Europe, which is one of two studies currently in the planning stages, will investigate the safety and feasibility of adipose stem and regenerative cells for chronic ischemia.

In the study, cells will be processed using the Celution system and delivered using a NOGA, mapping and delivery system in the same approach used for the preclinical study. The randomized, placebo-controlled dose-escalation study will enrol up to 36 patients with chronic ischemia who are not eligible for coronary artery bypass surgery or percutaneous coronary intervention.

Cytori Therapeutics, Inc. is discovering and developing proprietary cell based therapeutics, utilizing adult stem and regenerative cells, derived from adipose tissue, also known as fat. The Company's investigational therapies target cardiovascular disease, spine and orthopaedic conditions, gastrointestinal disorders and new approaches for aesthetic and reconstructive surgery.