Public HealthCytori Completes Enrollment In First Adipose Stem & Regenerative Cell Therapy Trial For Chronic Heart Disease
Cytori (NASDAQ:CYTX) completed enrollment in the first study to investigate adipose derived stem and regenerative cells in chronic heart disease. The trial, which has been named the PRECISE study, was carried out at leading cardiology centers in Europe. It specifically enrolled patients suffering from an advanced form of chronic heart disease, known as chronic myocardial ischemia, for which there is no generally accepted treatment.
The trial enrolled 27 patients and was designed as a double-blind, randomized, placebo controlled, dose escalation study. It is unique in that the patients" own cells 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.
The primary objectives of the study were to assess safety and feasibility of Cytori"s Celution® System as part of a novel procedure for chronic heart disease. The Company believes it will be able to fully assess these primary objectives with the data obtained from 27 patients (the protocol allowed for up to 36 patients). Further, the independent data safety and monitoring board had not identified any safety concerns relating to the Celution® output or the procedure. Six month results are expected in the first half of 2010.
"This represents a significant development in the field of cardiac cell therapy," said Emerson Perin, M.D., Director of the New Interventional Cardiovascular Technology and Director of the Stem Cell Center at the Texas Heart Institute and co-principal investigator for PRECISE. "Should the Celution® System output prove efficacious in this patient population, this novel treatment could constitute a completely new approach in obtaining stem cells that may be of therapeutic benefit to the heart."
"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," added Professor Francisco Fernandez-Avilés, Professor of Medicine and Chair of the Department of Cardiology at Hospital General Universitario Gregorio MarañÃön and co-principal investigator. "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. A similar device configured for cosmetic and reconstructive surgery is currently being sold into the European and Asia Pacific markets. Cardiovascular disease is the most advanced therapeutic application in Cytori"s product development pipeline.
"We would like to sincerely thank the patients for participating in the study as well as the investigators and hospital staff for their expertise and dedication," said Marc H. Hedrick, M.D., president of Cytori Therapeutics. "The outcomes of this study will serve as the foundation for design and initiation of the next phase of clinical development of the Celution® System for chronic cardiovascular disease."
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