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Henry McCusker
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Editor and Publisher ... Henry enters his twelve (12) year at Scimitar's RegMed 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 high-impact synthesis. He was VP -... More
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  • Cytori Therapeutics (CYTX), Post-Hoc APOLLO Study 1 comment
    Jan 21, 2011 11:30 AM
    Adipose-Derived Regenerative Cell (ADRC) therapy associated with reduction in arrhythmia in acute heart attack patients.

    CYTX presented data reported at the 6th International Conference on Cell Therapy for Cardiovascular Disease demonstrating a statistically significant reduction in ventricular tachyarrhythmia following adipose-derived regenerative cell (ADRC) therapy in patients with acute heart attack.

    • The findings were presented by Henricus J. Duckers, M.D., Ph.D., Interventional Cardiologist, Head of Molecular Cardiology, Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands.

    In Dr. Duckers’ presentation, ADRC therapy was associated with a significantly lower incidence of ventricular tachyarrhythmia.

    • A total of 3 episodes of ventricular tachyarrhythmia were reported in the treated group as compared to 10 in the control group (p=0.018);
    • On a per patient basis, the treated group experienced a mean of 0.3 episodes of ventricular tachyarrhythmia as compared to 2.5 in the control group (p=0.048);
    • The analysis of Holter recordings also indicated lower incidence of premature ventricular contractions (PVC, a single abnormal beat) in patients treated with ADRCs. In ADRC-treated patients, 5 PVCs per patient, per day, were reported whereas in placebo-treated patients, the number of PVCs reported per patient, per day, was 72 (p=0.014);
    • Forty-eight hour Holter recordings were obtained weekly for the first month after discharge followed by 24-hour recordings at 2, 3, 4 and 6 months post-procedure. All Holter recordings were assessed by an independent, blinded Holter core laboratory. Post-hoc data analyses of Holter data were conducted independently by Thoraxcentre.

    Although … not the primary study endpoint, the observed reduction in arrhythmias supports … the safety of ADRCs in the treatment of patients with an acute heart attack.

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  • yellowtailcheek
    , contributor
    Comments (50) | Send Message
     
    wonder why cytx kept on skirting the USFDA trial and did all those small scale trials in other places with no help in selling the product.

     

    the way i see it, a third class medical device company with a third class device looking for a "new drug status"... because they couldn't win in device market - 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, 12:53 PM Reply Like
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