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

• Published in: European heart journal Vol. 30; no. 11; pp. 1313 - 1321
• Main Authors: Tendera, Michał, Wojakowski, Wojciech, Rużyłło, Witold, Chojnowska, Lidia, Kępka, Cezary, Tracz, Wiesława, Musiałek, Piotr, Piwowarska, Wiesława, Nessler, Jadwiga, Buszman, Paweł, Grajek, Stefan, Bręborowicz, Piotr, Majka, Marcin, Ratajczak, Mariusz Z.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.06.2009; Oxford Publishing Limited (England)
• Subjects: Adult; Aged; Angioplasty, Balloon, Coronary; Biological and medical sciences; Bone marrow progenitor cells; Bone Marrow Transplantation - methods; Cardiac Output, Low - therapy; Cardiology. Vascular system; Cardiovascular system; Coronary Angiography; Coronary heart disease; CXCR4+ cells; Drug Administration Schedule; Female; Heart; Humans; Intracoronary infusion; Investigative techniques of hemodynamics; Investigative techniques, diagnostic techniques (general aspects); Magnetic Resonance Imaging; Male; Medical sciences; Middle Aged; Myocardial infarction; Myocardial Infarction - physiopathology; Myocardial Infarction - therapy; Myocarditis. Cardiomyopathies; Prospective Studies; Research Design; Stroke Volume; Ventricular Dysfunction, Left - physiopathology; Ventricular Dysfunction, Left - therapy; Myocardial infarction; CXCR4; cells; Intracoronary infusion; Bone marrow progenitor cells; Stem cell; Cardiovascular disease; Myocardial disease; Result; Infusion; Randomization; Mononuclear cell; Bone marrow; Population; Ventricular ejection; Cardiology; Human; Acute; Coronary artery; Coronary heart disease; Left ventricle; Regeneration; Perfusion; Myocardium; Circulatory system; Hemodynamics; Progenitor cell; Ejection fraction
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehp073

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.