title: Comparison of Different Bone Marrow-Derived Stem Cell Approaches in Reperfused STEMI. A Multicenter, Prospective, Randomized, Open-Labeled TECAM Trial.
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.
  
  
  OBJECTIVE
  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).
authors.affiliation: Department of Cardiology, Instituto de Ciencias del Corazón, Valladolid, Spain.
authors.forename: J Alberto
authors.initials: JA
authors.lastname: San Roman
authors.affiliation: Department of Cardiology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain; Department of Cardiology, Instituto de Investigación Sanitaria, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Sánchez
authors.affiliation: Department of Cardiology, Instituto de Investigación Sanitaria, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Villa
authors.affiliation: Department of Cardiology, Instituto de Investigación Sanitaria, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Sanz-Ruiz
authors.affiliation: Department of Cardiology, Instituto de Investigación Sanitaria, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: María Eugenia
authors.initials: ME
authors.lastname: Fernandez-Santos
authors.affiliation: Department of Cardiology, Instituto de Ciencias del Corazón, Valladolid, Spain.
authors.forename: Federico
authors.initials: F
authors.lastname: Gimeno
authors.affiliation: Department of Cardiology, Instituto de Ciencias del Corazón, Valladolid, Spain.
authors.forename: Benigno
authors.initials: B
authors.lastname: Ramos
authors.affiliation: Department of Cardiology, Instituto de Ciencias del Corazón, Valladolid, Spain.
authors.forename: Roman
authors.initials: R
authors.lastname: Arnold
authors.affiliation: Department of Cardiology, Instituto de Ciencias del Corazón, Valladolid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Serrador
authors.affiliation: Department of Cardiology, Instituto de Ciencias del Corazón, Valladolid, Spain.
authors.forename: Hipólito
authors.initials: H
authors.lastname: Gutiérrez
authors.affiliation: Department of Cardiology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Martin-Herrero
authors.affiliation: Department of Cardiology, Hospital Río Hortega, Valladolid, Spain.
authors.forename: María Jesús
authors.initials: MJ
authors.lastname: Rollán
authors.affiliation: Department of Cardiology, Complejo Hospitalario de León, León, Spain.
authors.forename: Felipe
authors.initials: F
authors.lastname: Fernández-Vázquez
authors.affiliation: Intensive Care Unit, Hospital Río Carrión, Palencia, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: López-Messa
authors.affiliation: Intensive Care Unit, Hospital de Segovia, Segovia, Spain.
authors.forename: Pablo
authors.initials: P
authors.lastname: Ancillo
authors.affiliation: Cardiology Department, Hospital General Yague, Burgos, Spain.
authors.forename: German
authors.initials: G
authors.lastname: Pérez-Ojeda
authors.affiliation: Department of Cardiology, Instituto de Investigación Sanitaria, Hospital General Universitario Gregorio Marañón, Madrid, Spain. Electronic address: faviles@secardiologia.es.
authors.forename: Francisco
authors.initials: F
authors.lastname: Fernández-Avilés
mesh_terms: D001854:Bone Marrow Cells / Q000166:cytology*; D017023:Coronary Angiography; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007279:Injections, Subcutaneous; D019028:Magnetic Resonance Imaging, Cine; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D020127:Recovery of Function; D015424:Reperfusion; D033581:Stem Cell Transplantation / Q000379:methods*; D013318:Stroke Volume; D014182:Transplantation, Autologous
chemical_list: D016179:Granulocyte Colony-Stimulating Factor
keywords: cardiac function; granulocyte colony-stimulating factor; magnetic resonance; mononuclear