Healthcare Industry News: Cytori Therapeutics
News Release - January 3, 2007
Cytori to Begin Stem Cell Trial for Heart DiseaseThe Company is Initiating Its PRECISE Trial for Chronic Ischemia
SAN DIEGO--(HSMN NewsFeed)--Cytori Therapeutics (NASDAQ:CYTX ; FWB:XMPA) received approvals to initiate a clinical trial in Spain to investigate the use of adipose-derived stem and regenerative cells for the treatment of cardiovascular disease. The cells will be obtained at the bedside from the patients' own adipose (fat) tissue, the richest source of adult stem cells, and made available in real-time using Cytori's Celution(TM) stem and regenerative cell processing system. Patient enrollment will begin imminently.
Cytori's trial, designated as the 'PRECISE' study, will primarily evaluate safety and feasibility in 36 patients with chronic ischemia, a severe form of coronary artery disease. The Company's Celution(TM) stem and regenerative cell processing system will extract and concentrate a patient's cells in the catheterization suite so they are available for the physician to re-inject into damaged heart muscle in about an hour. A variety of clinical functional and imaging endpoints will be assessed in the study. The outcomes of the study will be evaluated after a six-month follow up.
"We believe this study will be an important advance for patients with cardiovascular disease," said Alex Milstein, Vice President, Clinical Development for Cytori Therapeutics. "With this approval to begin our first company-sponsored clinical trial of the Celution(TM) adipose stem and regenerative cell processing system, our clinical development timeline remains on track. We expect to present the six-month outcomes of this study in 2008."
The trial site for the PRECISE study is Hospital General Universitario Gregorio Maranon in Madrid, Spain. Professor Francisco Fernandez-Aviles, Prof. of Cardiovascular Medicine and Chief of Cardiology Service at Gregorio Maranon, and Dr. Emerson Perin, Director of New Interventional Cardiovascular Technology and Director of Stem Cell Center at the Texas Heart Institute, will also serve as co-principal investigators.
The customary process of obtaining clinical trial approval in Spain includes two steps. First is the review by the Ethical committee and the second is review by the Ministry of Health. Ethical committee approval was received in November 2006 and verbal approval by the ministry was received December 2006.
About Cytori Therapeutics
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 orthopedic conditions, gastrointestinal disorders, and new approaches for aesthetic and reconstructive surgery. To facilitate processing and delivery of adipose stem and regenerative cells, Cytori has developed its proprietary Celution(TM) System to isolate and concentrate a patient's own stem and regenerative cells in about an hour. This system will dramatically improve the speed in which personalized cell-based therapies can be delivered to patients.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and prospects of our business which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses and expected continuing losses, the need for further financing, our ability to develop and commercialize regenerative cell-based therapies, our dependence on third parties, our ability to obtain, defend and enforce our intellectual property, and other risks and uncertainties described (under the heading "Risk Factors") in Cytori Therapeutics' Form 10-K annual report for the year ended December 31, 2005 and subsequent SEC 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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