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Stem Cell Heart Attack Trial in EU, Cytori Therapeutics (CYTX)

First ADVANCE trial site to begin enrollment in the Netherlands

CYTX 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 1st 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, its next generation device manufactured by Olympus-Cytori Joint Venture;
  • The Celution® One System is an investigational device that is not yet commercially available.

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.