title: Autologous stem cell transplantation in acute myocardial infarction: The ASTAMI randomized controlled trial. Intracoronary transplantation of autologous mononuclear bone marrow cells, study design and safety aspects.
abstract: OBJECTIVE
  Intracoronary transplantation of different cell populations has been used in acute myocardial infarction (AMI) with promising results. The primary objective of the Autologous Stem cell Transplantation in Acute Myocardial Infarction (ASTAMI) study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improves left ventricular ejection fraction (LVEF) after anterior wall AMI.
  
  
  METHODS
  The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute percutaneous coronary intervention (PCI) are randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 d after PCI or to control. Left ventricular function, exercise capacity, biochemical status, functional class, quality of life and complications are validated at baseline and during a 12-month follow-up.
  
  
  RESULTS
  By August 2004, out of 1004 patients with STEMI, 49 patients have been included in the study. Twenty-four patients have been randomized to intracoronary mBMC transplantation. Twenty patients had chest pain and 16 patients had ischemic ECG changes during the mBMC transplantation procedure. One patient had ventricular fibrillation 24 h after transplantation.
  
  
  CONCLUSIONS
  Intracoronary transplantation of autologous mBMC in the acute phase after AMI is feasible and seems safe in the short term.
authors.affiliation: Department of Cardiology, Rikshospitalet University Hospital, Oslo, Norway. ketil.lunde@rikshospitalet.no
authors.forename: Ketil
authors.initials: K
authors.lastname: Lunde
authors.forename: Svein
authors.initials: S
authors.lastname: Solheim
authors.forename: Svend
authors.initials: S
authors.lastname: Aakhus
authors.forename: Harald
authors.initials: H
authors.lastname: Arnesen
authors.forename: Michael
authors.initials: M
authors.lastname: Abdelnoor
authors.forename: Kolbjørn
authors.initials: K
authors.lastname: Forfang
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D001854:Bone Marrow Cells; D016022:Case-Control Studies; D017079:Exercise Tolerance; D005260:Female; D006801:Humans; D007963:Leukocytes, Mononuclear; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000601:surgery*; D033581:Stem Cell Transplantation; D013318:Stroke Volume; D014182:Transplantation, Autologous