European Heart Journal Advance Access originally published online on February 10, 2009
European Heart Journal 2009 30(11):1313-1321; doi:10.1093/eurheartj/ehp073
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Intracoronary infusion of bone marrow-derived selected CD34+CXCR4+ cells and non-selected mononuclear cells in patients with acute STEMI and reduced left ventricular ejection fraction: results of randomized, multicentre Myocardial Regeneration by Intracoronary Infusion of Selected Population of Stem Cells in Acute Myocardial Infarction (REGENT) Trial
Tendera1,*
yo2
pka2awa Tracz3ek3awa Piwowarska4 Buszman1borowicz5
1 Third Division of Cardiology, Medical University of Silesia, 45-47 Zioowa Street, 40-635 Katowice, Poland
2 First Department of Coronary Artery Disease and Catheterization Laboratory, Institute of Cardiology, Warsaw, Poland
3 Department of Cardiac and Vascular Diseases, Jagiellonian University, Kraków, Poland
4 Department of Coronary Disease, Jagiellonian University, Kraków, Poland
5 First Department of Cardiology, Pozna
University of Medical Sciences, Pozna, Poland
6 Department of Transplantology, Polish-American Children's Hospital, Medical College, Jagiellonian University, Kraków, Poland
7 Stem Cell Institute, University of Louisville, Louisville, KY, USA
Received 3 November 2008; revised 12 January 2009; accepted 30 January 2009; online publish-ahead-of-print 10 February 2009.
* Corresponding author. Tel: +48 32 2523930, Fax: +48 32 2523930, Email: michal.tendera{at}gmail.com
See page 1310 for the editorial comment on this article (doi:10.1093/eurheartj/ehp181)
Aims: Comparison of intracoronary infusion of bone marrow (BM)-derived unselected mononuclear cells (UNSEL) and selected CD34+CXCR4+ cells (SEL) in patients with acute myocardial infarction (AMI) and reduced <40% left ventricular ejection fraction (LVEF).
Methods and results: Two hundred patients were randomized to intracoronary infusion of UNSEL (n = 80) or SEL (n = 80) BM cells or to the control (CTRL) group without BM cell treatment. Primary endpoint: change of LVEF and volumes measured by magnetic resonance imaging before and 6 months after the procedure. After 6 months, LVEF increased by 3% (P = 0.01) in patients treated with UNSEL, 3% in patients receiving SEL (P = 0.04) and remained unchanged in CTRL group (P = 0.73). There were no significant differences in absolute changes of LVEF between the groups. Absolute changes of left ventricular end-systolic volume and left ventricular end-diastolic volume were not significantly different in all groups. Significant increase of LVEF was observed only in patients treated with BM cells who had baseline LVEF < median (37%). Baseline LVEF < median and time from the onset of symptoms to primary percutaneous coronary intervention 
median were predictors of LVEF improvement in patients receiving BM cells. There were no differences in major cardiovascular event (death, re-infarction, stroke, target vessel revascularization) between groups.
Conclusion: In patients with AMI and impaired LVEF, treatment with BM cells does not lead to a significant improvement of LVEF or volumes. There was however a trend in favour of cell therapy in patients with most severely impaired LVEF and longer delay between the symptoms and revascularization.
Key Words: Bone marrow progenitor cells • Myocardial infarction • CXCR4+ cells • Intracoronary infusion
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