Comparison of Different Bone Marrow-Derived Stem Cell Approaches in Reperfused STEMI. A Multicenter, Prospective, Randomized, Open-Labeled TECAM Trial
J Alberto San Roman, Pedro L Sánchez, Adolfo Villa, Ricardo Sanz-Ruiz, María Eugenia Fernandez-Santos, Federico Gimeno, Benigno Ramos, Roman Arnold, Ana Serrador, Hipólito Gutiérrez, Francisco Martin-Herrero, María Jesús Rollán, Felipe Fernández-Vázquez, Juan López-Messa, Pablo Ancillo, German Pérez-Ojeda, Francisco Fernández-Avilés, J Alberto San Roman, Pedro L Sánchez, Adolfo Villa, Ricardo Sanz-Ruiz, María Eugenia Fernandez-Santos, Federico Gimeno, Benigno Ramos, Roman Arnold, Ana Serrador, Hipólito Gutiérrez, Francisco Martin-Herrero, María Jesús Rollán, Felipe Fernández-Vázquez, Juan López-Messa, Pablo Ancillo, German Pérez-Ojeda, Francisco Fernández-Avilés
Abstract
Background: Stem cell-based therapy has emerged as a potential therapy in acute myocardial infarction (AMI). Although various approaches have been studied, intracoronary injection of bone marrow autologous mononuclear cells (BMMC) and the ability of granulocyte colony-stimulating factor (G-CSF) to mobilize endogenous cells have attracted the most attention.
Objectives: This study compares, for the first time, the efficacy of BMMC injection, G-CSF mobilization, and the combination of both with standard treatment.
Methods: On Day 1 after primary percutaneous coronary intervention, 120 patients were randomized to a 1) intracoronary BMMC injection; 2) mobilization with G-CSF; 3) both (BMMC injection plus G-CSF); or 4) conventional treatment (control group). G-CSF, 10 μg/kg/day subcutaneously, was started Day 1 and maintained for 5 days. BMMC injection was performed on Days 3 to 5. Our primary endpoint was absolute change in 12-month left ventricular ejection fraction (LVEF) and left ventricular end-systolic volume (LVESV) relative to baseline measured by cardiac magnetic resonance.
Results: The mean change in LVEF between baseline and follow-up for all patients was 4 ± 6% (p = 0.006). Change in LVEF and LVESV over time did not differ significantly among the 4 groups. Patients actively treated with any stem cell approach showed similar changes in LVEF and LVESV versus control subjects, with a small but significant reduction in infarct area (p = 0.038).
Conclusions: In our study, 3 different bone marrow-derived stem cell approaches in AMI did not result in improvement of LVEF or volumes compared with standard AMI care (Trial of Hematopoietic Stem Cells in Acute Myocardial Infarction [TECAM]; NCT00984178).
Keywords: cardiac function; granulocyte colony-stimulating factor; magnetic resonance; mononuclear.
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed