The Celution system is used to prepare adipose-derived stem and regenerative cells (ADRCs) to treat chronic myocardial ischemia (CMI).
The IDE approval allows Cytori to start a double blind, multi-center, placebo controlled, pilot, randomized Athena trial.
The trial is designed to demonstrate the use of autologous, clinical-grade ADRCs, processed at the point-of-care with Cytori’s proprietary Celution System.
The trial will enroll up to 45 patients with no-option CMI who have limited therapeutic options.
The trial will evaluate a variety of clinical and functional outcomes, including safety, peak oxygen consumption (mVO2), and clinical outcomes at 12-months.
Cytori CEO Christopher Calhoun said they look forward to work with the FDA on further defining their clinical strategy in the US.
The company said it is also enrolling Advance, a European pivotal trial investigating the Celution System for acute myocardial infarction (heart attacks).
