Stem cell mobilization by granulocyte colony-stimulating factor in patients with acute myocardial infarction: a randomized controlled trial.
BACKGROUND
Experimental studies and early phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived stem cells may improve cardiac regeneration and neovascularization after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells.


OBJECTIVE
To assess the value of stem cell mobilization by G-CSF therapy in patients with acute myocardial infarction.


METHODS
Randomized, double-blind, placebo-controlled trial of patients diagnosed with ST-segment elevation acute myocardial infarction who had successful reperfusion by percutaneous coronary intervention within 12 hours after onset of symptoms in Germany between February 24, 2004, and February 2, 2005.


METHODS
Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.


METHODS
The primary end point was reduction of left ventricular infarct size according to technetium Tc 99m sestamibi scintigraphy performed at baseline and at 4 to 6 months after randomization. Secondary end points included improvement of left ventricular ejection fraction measured by magnetic resonance imaging and the incidence of angiographic restenosis.


RESULTS
Of the 114 patients, 56 were assigned to receive treatment with G-CSF and 58 were assigned to receive placebo. Treatment with G-CSF produced a significant mobilization of stem cells. Between baseline and follow-up, left ventricular infarct size according to scintigraphy was reduced by a mean (SD) of 6.2% (9.1%) in the G-CSF group and 4.9% (8.9%) in the placebo group (P = .56) and left ventricular ejection fraction was improved by 0.5% (3.8%) in the G-CSF group and 2.0% (4.9%) in the placebo group (P = .14). Angiographic restenosis occurred in 19 (35.2%) of 54 patients in the G-CSF group and in 17 (30.9%) of 55 patients in the placebo group (P = .79). The most common adverse event among patients assigned to G-CSF was mild to moderate bone pain and muscle discomfort.


CONCLUSIONS
Stem cell mobilization by G-CSF therapy in patients with acute myocardial infarction and successful mechanical reperfusion has no influence on infarct size, left ventricular function, or coronary restenosis.


BACKGROUND
ClinicalTrials.gov Identifier: NCT00126100.
Zohlnhöfer
Dietlind
D
Deutsches Herzzentrum, Technische Universität München, Munich, Germany.
Ott
Ilka
I
Mehilli
Julinda
J
Schömig
Kathrin
K
Michalk
Fabian
F
Ibrahim
Tareq
T
Meisetschläger
Günther
G
von Wedel
Jasper
J
Bollwein
Hildegard
H
Seyfarth
Melchior
M
Dirschinger
Josef
J
Schmitt
Claus
C
Schwaiger
Markus
M
Kastrati
Adnan
A
Schömig
Albert
A
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D018952:Antigens, CD34 / Q000097:blood; D017023:Coronary Angiography; D023903:Coronary Restenosis; D004311:Double-Blind Method; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006321:Heart / Q000000981:diagnostic imaging; D006352:Heart Ventricles / Q000473:pathology; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D015899:Tomography, Emission-Computed, Single-Photon; D016277:Ventricular Function, Left
D018952:Antigens, CD34; D016179:Granulocyte Colony-Stimulating Factor