The Cardiovascular Cell Therapy Research Network (CCTRN) has selected Cytori Therapeutics 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.
CELLVAD-ADRC is a prospective, phase I, double-blind, randomised trial that will enrol 34 patients with end-stage ischaemic 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 randomised 1:1 to receive either adipose-derived regenerative cells 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 enrolment across its network of seven US trial sites, which lead the field of cardiovascular cell therapy.
Cytori Cell Therapy is a mixed population of autologous adipose-derived regenerative cells 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.
The Celution system is available in the United States for investigational use only.