The Cardiovascular Cell Therapy Research Network (CCTRN), has selected Cytori (NASDAQ: CYTX) Therapeutics, Inc. to supply adipose-derived regenerative cells (ADRCs™) for a clinical trial aimed at evaluating the safety and feasibility of treating patients with Left Ventricular Assist Devices (LVADs). The CCTRN is supported by grants from the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH). This trial, named CELLVAD-ADRC, will explore outcomes following administration of a regenerative cell preparation from adipose tissue into the patient’s heart muscle 60 to 90 days after placement of an LVAD. “Cytori is honored to have been selected by the CCTRN to collaborate on this trial. The CELLVAD-ADRC trial is consistent with our commitment to developing cell therapies for heart failure,” said Marc H. Hedrick, President and CEO of Cytori Therapeutics. “We look forward to understanding how ADRCs may benefit patients with a more advanced stage of heart failure than those being treated in our U.S. ATHENA trial.” CELLVAD-ADRC is a prospective, phase I, double-blind, randomized trial that will enroll 34 patients with end-stage ischemic heart disease who have received an LVAD in the preceding 60 to 90 days. Following an open-label phase where the initial 10 patients will all receive cell therapy subject to a safety committee review, 24 patients will be randomized 1:1 to receive either ADRCs or a placebo. The trial will assess safety and feasibility endpoints including adverse events, cardiac function, exercise tolerance, myocardial viability and perfusion, and quality of life over a one year follow-up period. The trial is funded by the NHLBI through its Cardiovascular Cell Therapy Research Network (CCTRN), which will oversee trial design, implementation, and enrollment across its network of seven U.S. trial sites, which lead the field of cardiovascular cell therapy. Cytori Cell Therapy is a mixed population of autologous adipose-derived regenerative cells (ADRCs™) extracted using Cytori’s innovative and proprietary Celution® System, creating new treatment opportunities for currently unmet medical needs. Adipose tissue is the richest source of stem and regenerative cells in the body. LVADs are mechanical devices used in hearts too weak to pump blood throughout the body. They are commonly implanted in patients waiting for a transplant or who do not qualify for a transplant but need additional pumping support.
According to the American Heart Association, there are approximately 5.1 million Americans currently living with heart failure. For patients with a more advanced condition of heart failure, Ventricular Assist Devices are sometimes an option. In 2010, more than 1,400 LVAD devices were implanted into patients in the U.S. alone.About Cardiovascular Cell Therapy Research Network (CCTRN) and NHLBI The CCTRN consists of a data coordinating center and seven medical centers in the United States with expertise in stem cell-based clinical trials for cardiovascular diseases. The CCTRN has successfully completed and published the results of three adult stem cell trials to date (TIME, LateTIME, and FOCUS) and is currently executing a study of regenerative cell therapy for peripheral arterial disease called PACE. Further information on CCTRN is available at: cctrn.org. The National Heart, Lung, and Blood Institute (NHLBI) is a component of the National Institutes of Health (NIH). NHLBI plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available at: nhlbi.nih.gov. About Cytori Therapeutics Cytori Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs™) to treat cardiovascular disease and other medical conditions. Our scientific data suggest ADRCs™ improve blood flow, modulate the inflammatory response and rescue tissue at risk of dying. As a result, we believe these cells can be applied across multiple “ischemic” conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori’s proprietary technologies and products, including the Celution® System product family. www.cytori.com Cautionary Statement Regarding Forward-Looking Statements This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements including those regarding NHLBI’s intent to enroll 34 patients in the CELLVAD-ADRC trial, are subject to risks and uncertainties that could cause the scope of the trial to change from the approved plan. Some of these risks include clinical and regulatory uncertainties, risks in the collection and results of clinical data, clinical outcomes, dependence on third party performance, and 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.
The Celution® System is available in the United States for investigational use only.