Safety Study of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction
Summary
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
Timeline
- Start
- 2008-03
- Primary completion
- 2013-12
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic Mesenchymal Precursor Cells (MPCs) | Cell therapy | 25 cells | Other |
| Subject | Allogeneic Mesenchymal Precursor Cells (MPCs) | Cell therapy | 75 cells | Other |
| Subject | Allogeneic Mesenchymal Precursor Cells (MPCs) | Cell therapy | 150 cells | Other |