Regenerative medicine technology company Cytori is all set to investigate adipose derived stem cells and regenerative cells in the trial of chronic heart disease.
The trial was carried out at leading cardiology centers in Europeis named as PRECISE study, It enrolled 27 patients (the protocol allowed for up to 36 patients) patients who were specifically suffering from an advanced form of chronic heart disease, known as chronic myocardial ischemia, for which there is no generally accepted treatment.
During ischemia, an imbalance occurs between myocardial oxygen supply and demand. Myocardial ischemia is a condition in which oxygen deprivation to the heart muscle is accompanied by inadequate removal of metabolites because of reduced blood flow or perfusion.
Myocardial ischemia can occur as a result of increased myocardial oxygen demand, reduced myocardial oxygen supply, or both. In the presence of coronary obstruction, an increase of myocardial oxygen requirements caused by exercise, tachycardia, or emotion leads to a transitory imbalance.
In the trial patients own cell were extracted from adipose tissue and processed for delivery at the point of care using Cytori’s Celution® System. The cells were then injected back into the patients using the NOGA® XP System (Biologics Delivery Systems, Cordis Corp., a Johnson and Johnson company), which identifies and guides cells to damaged regions of the heart.
According to prof. Francisco Fernandez-Avilés, Professor of Medicine and Chair of the Department of Cardiology at Hospital General Universitario Gregorio Marañón and co-principal investigator, The advantage to Cytori’s approach to cardiac cell therapy is that the Celution® System is the only technology that prepares a patient’s own cells at the point of care during a single surgical procedure.
A major attribute of the Celution® output is that it is comprised of multiple cells types. This we believe contributes to multiple mechanisms of action, and thus increases the potential to restore heart function.
The Celution® System used in PRECISE was configured specifically for cardiovascular disease, including proprietary processes and enzymes needed to achieve a level of purity required for vascular delivery.
Cytori’s technology is incorporated into two product families.
a) The Celution®-related products, which are sold throughout Europe and Asia primarily into the cosmetic and reconstructive surgery market and are under evaluation by the U.S. FDA.
b) The StemSource® products, which are sold globally for cell banking and research applications.
For further information:
Cytori Therapeutics, Inc.
Tom Baker, 858-875-5258