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.
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.
Lunde
Ketil
K
Department of Cardiology, Rikshospitalet University Hospital, Oslo, Norway. ketil.lunde@rikshospitalet.no
Solheim
Svein
S
Aakhus
Svend
S
Arnesen
Harald
H
Abdelnoor
Michael
M
Forfang
Kolbjørn
K
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