The purpose of the study is to compare the efficiency of a sorted subpopulation of CD34+/CXCR4+ cells and unselected bone marrow-derived progenitor cells in the treatment of patients with acute myocardial infarction and a low left ventricular ejection fraction.
Aim is to compare the efficiency of sorted subpopulation of CD34+/CXCR4+ cells and unselected bone-marrow-derived progenitor cells in treatment of patients with acute myocardial infarction and low left ventricular ejection fraction. The subpopulation of CD34+/CXCR4+ cells most likely contains the tissue-specific stem cells likely to be involved in myocardial salvage/regeneration after ischemic injury. This approach is novel and original, because so far no study identified the type of cells that actually contribute to stem cell-induced improvement in myocardial function in patients with AMI which were treated with unselected population of cells. The REGENT trial (prospective, randomized, multicentre trial comparing unselected BM mononuclear cells and sorted CD34/CXCR4+ cells in patients with myocardial infarction and low left ventricular ejection fraction) successfully treated with primary percutaneous coronary angioplasty within 12 hours after the onset of chest pain. The cells are delivered by intracoronary infusion. Efficiency is assessed by cardiac magnetic resonance imaging, echocardiography and left ventricular angiography.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
III Division of Cardiology Silesian School of Medicine
Katowice, Poland
Jagiellonian University Institute of Cardiology
Krakow, Poland
Poznan University of Medical Sciences II Clinic of Cardiology
Poznan, Poland
National Institute of Cardiology
Warsaw, Poland
Left ventricular ejection fraction and volumes measured by echocardiography
Time frame: 6 months
Left ventricular ejection fraction and volumes measured by angiography
Time frame: 6 months
Safety
Time frame: 6, 12 months
Left ventricular function in dobutamine stress test
Time frame: 6 months
Coronary flow reserve by adenosine MRI test
Time frame: 6 months
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