Myocardial Infarction Clinical Trial
Official title:
A Phase 1b/2a Dose Escalation Study to Assess the Safety and Feasibility of Transendocardial Delivery of 3 Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction
Primary Objective The primary objective of this study is to evaluate the safety and
feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping
Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of 25 M, 75 M, and
150 M allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.
SecondaryObjective
The secondary objectives are to explore functional efficacy for subsequent study design, as
well as late-term dose related tolerance, by:
- Evaluating the effect of allogeneic MPCs on exploratory efficacy endpoints related to
cardiac function on Days 90, 180, and 1 year
- Evaluating the change from baseline in the Medical Outcome Study Short Form (SF-36),
Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and the New
York Heart Association Classification at 30 days, 3 and 6 months, and 1, 2, and 3 years
- Evaluating follow-up safety through Day 360
- Providing preliminary data to support dose selection for future studies
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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