Cytori received approval from The Netherlands to initiate a pivotal European trial, named ADVANCE, to investigate adipose-derived stem and regenerative cells (ADRCs), processed by the Celution® One System, in the treatment of patients with acute heart attacks. This is the first country and trial-center approval for ADVANCE.
Additional country and trial-center approvals are anticipated throughout Europe during the first half of 2011. One of the goals of the trial is to expand the Celution® System CE Mark to include acute heart attack claims and to provide economic data to justify its implementation and reimbursement.
ADVANCE is a randomized, placebo controlled, double-blind trial that will enroll up to 360 patients with ST-elevation myocardial infarction in up to 35 centers, predominately in Europe. The primary endpoint of the trial is reduction in infarct size as measured by cardiac magnetic resonance imaging (MRI).
ADVANCE will use the Celution® One, our next generation device manufactured by Olympus-Cytori Joint Venture. The Celution® One System draws on the same core technology and scientific innovation as the Celution® 800 System, which is currently approved in Europe for breast reconstruction, certain aesthetic procedures and specific types of wounds.
The Celution® One System is an investigational device that is not yet commercially available. The Celution® One System is specifically designed for use in a hospital setting, processing greater tissue volumes in less time.
In 2010, Cytori reported results from the APOLLO trial, a pilot study for acute heart attack patients who underwent ADRC therapy. The study showed that the harvest and injection of ADRCs were safe and well-tolerated in this patient population. At 6 months, the procedure was associated with an improvement in infarct size in ADRC-treated patients, as well as in other measures.