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 at baseline and 6 months
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Other Endpoints
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Secondary endpoints to determine preservation of cardiac function and clinical events:
CMR to measure LVEF, LVESV, LVEDV, regional myocardial strain, infarct/peri-infarct regional wall motion abnormalities, and infarct size (baseline and 6 months)
Quality of Life measures: (KCCQ & SAQ*)
Reduction in cumulative MACE and other adverse clinical cardiac events - 6, 12, 18, 24, and 36 months
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Frequency of Treatment
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Single Dose
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Dosing
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Minimum dose for release ≥10m cells
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Randomization
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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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18 months from initiation (12 month accrual and 6 month follow-up): Perfusion, cardiac function, QOL* and other clinical events
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* KCCQ: Kansas City Cardiomyopathy Questionnaire
SAQ: Seattle Angina Questionnaire
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