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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
25 M allogeneic MPCs by transendocardial injection
Standard-of-care treatment with NOGA® mapping and staged injections.
75 M allogeneic MPCs by transendocardial injection
Standard-of-care treatment with NOGA® mapping and staged injections.
150 M allogeneic MPCs by transendocardial injection
Standard-of-care treatment with NOGA® mapping and staged injections.
University of Minnesota/Minneapolis Heart Institute
Minneapolis, Minnesota, United States
RECRUITINGTexas Heart Institute/St. Luke's Hospital
Houston, Texas, United States
RECRUITINGEvaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.
Time frame: 30 days
Explore efficacy for subsequent study design and dose related tolerance: •Effect related to cardiac function.•Change from baseline in SF-36, KCCQ, SAQ, and the NYHA Classification.•Follow-up safety through Day 360 • Dose selection for future stu
Time frame: 3 years
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