Healthcare Industry News: Johnson and Johnson
News Release - May 27, 2009
Cytori Completes Enrollment in First Adipose Stem & Regenerative Cell Therapy Trial for Chronic Heart Disease
SAN DIEGO--(HSMN NewsFeed)--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 Marañón 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.”
About Cytori
Cytori develops and globally commercializes regenerative medicine technologies, which provide real-time, point-of-care access to clinical grade regenerative cells. Our technology is incorporated into two product families. The Celution®-related products are sold throughout Europe and Asia primarily into the cosmetic and reconstructive surgery market and are under evaluation by the U.S. FDA. Our StemSource® products are sold globally for cell banking and research applications. We are also developing additional clinical uses of our technology for the treatment of multiple medical conditions, including cardiovascular disease, urinary tract disorders, and wound related conditions. To commercialize our technology, Cytori has partnered with global and regional leaders in healthcare such as Olympus Corp, GE Healthcare, and Green Hospital Supply. www.cytoritx.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding the safety, efficacy, effects and availability of our products, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, as well as other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
Source: Cytori Therapeutics
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