October 22, 2014 — The Cardiovascular Cell Therapy Research Network (CCTRN) has selected Cytori Therapeutics Inc. to supply adipose-derived regenerative cells (ADRC) 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.
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 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 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.
For more information: www.nhlbi.nih.gov, www.cytori.com