Cytori Therapeutics has won the US Food and Drug Administration's (FDA) investigational device exemption (IDE) approval for its Celution system submitted in December 2011.
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).