In this blinded, randomized study, seven pigs received their own adipose stem and regenerative cells (treated) or a saline injection. 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% 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% 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 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,” said Dr Marc Hedrick, 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.”
The study was conducted by Dr Emerson Perin, at The Texas Heart Institute in collaboration with Cytori.