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Henry McCusker
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Analyst, Journalist and Publisher ... Henry enters his tenth (10) year at Scimitar Equity -Regenerative Medicine Investors which aggregates, curates and creates bottom-line content weeding of regenerative medicine and cell therapy news to provide a customized, vetted selection of relevant and... More
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  • Stem Cell Heart Attack Trial in EU, Cytori Therapeutics (CYTX) 1 comment
    Jan 20, 2011 6:18 PM

    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.
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  • yellowtailcheek
    , contributor
    Comments (55) | Send Message
    wonder why cytx kept on skirting the USFDA trial and did all those trials in other places if they truly believe ADSC has any value at all.


    the way i see it, a third grade medical device company with a third grade device looking for a new drug status - a lot of smoke and they actually fooled a lot of stupid money but they can't fool the USFDA, thank GOD....
    22 Jan 2011, 12:43 PM Reply Like
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