“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
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
About Cardiovascular Cell Therapy Research Network (CCTRN) and NHLBI
The CCTRN consists of a data coordinating center and seven medical centers in
The National Heart, Lung, and
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
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