The Phase II trial has been designed to evaluate the potential of AMR-001 to improve perfusion, preserve cardiac function and improve clinical outcomes. The trial is expected to include 160 patients in a placebo controlled, double-blind study. A composite of cardiac measures, including clinically meaningful endpoints, will support the primary endpoint of perfusion.
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Indication
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Post-AMI Preservation of Cardiac Function
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Primary Endpoint
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Increased Cardiac Perfusion (RTSS) measured by SPECT
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Other Endpoints
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A composite of endpoints will be used to determine overall cardiac function (including preservation of LVEF and prevention of adverse remodeling) and Quality of Life (KCCQ & SAQ*)
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Safety
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Reduction in cumulative MACE and other adverse events at 6, 12, 18, 24, and 36 months
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Dosing Frequency
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Single dose
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Dosing and Randomization
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Minimum dose for release >10 M cells
Randomized 1:1 treatment to sham placebo control
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Number of Subjects
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160 patients
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Number of Sites
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34
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Geography
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United States
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Trial Duration
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Perfusion, cardiac function and QOL at approximately 18 months post first enrollment (12 months of enrollment and 6 months of treatment)
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* KCCQ: Kansas City Cardiomyopathy Questionnaire
SAQ: Seattle Angina Questionnaire
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