J Alberto San Roman1, Pedro L Sánchez2, Adolfo Villa3, Ricardo Sanz-Ruiz3, María Eugenia Fernandez-Santos3, Federico Gimeno1, Benigno Ramos1, Roman Arnold1, Ana Serrador1, Hipólito Gutiérrez1, Francisco Martin-Herrero4, María Jesús Rollán5, Felipe Fernández-Vázquez6, Juan López-Messa7, Pablo Ancillo8, German Pérez-Ojeda9, Francisco Fernández-Avilés10. 1. Department of Cardiology, Instituto de Ciencias del Corazón, Valladolid, Spain. 2. Department of Cardiology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain; Department of Cardiology, Instituto de Investigación Sanitaria, Hospital General Universitario Gregorio Marañón, Madrid, Spain. 3. Department of Cardiology, Instituto de Investigación Sanitaria, Hospital General Universitario Gregorio Marañón, Madrid, Spain. 4. Department of Cardiology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain. 5. Department of Cardiology, Hospital Río Hortega, Valladolid, Spain. 6. Department of Cardiology, Complejo Hospitalario de León, León, Spain. 7. Intensive Care Unit, Hospital Río Carrión, Palencia, Spain. 8. Intensive Care Unit, Hospital de Segovia, Segovia, Spain. 9. Cardiology Department, Hospital General Yague, Burgos, Spain. 10. Department of Cardiology, Instituto de Investigación Sanitaria, Hospital General Universitario Gregorio Marañón, Madrid, Spain. Electronic address: faviles@secardiologia.es.
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).
RCT Entities:
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).
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