Cardiovascular Diseases Clinical Trial
Official title:
Autologous Mononuclear and Cluster of Differentiation 133+ (CD 133+) Bone Marrow Cells, Growth Factors and Cytokines in the Remodeling of the Heart in Patients During and in the Late Periods After STEMI.
The purpose of this study is to test the hypothesis that the intracoronary transplantation of autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular contractile function and will reduce the combined end points after the primary STEMI (mortality, recurrent myocardial infarction, angina, heart failure, stroke).
The study was randomized, opened, controlled. 85 patients with the first STEMI were enrolled.
Patients were divided to three groups. On admission all patients were received thrombolytic
therapy by 1,5 million U streptokinase. Transplantation of autologous mononuclear bone marrow
cells (BMMCs) and аutologous CD133 + cells by balloon catheter placed into infarct-related
artery (IRA) was performed at once after stent implantation in 28 patients patients (1st
group) and in 10 patients (2nd group) on the 7-21 days of STEMI. Another 47 patients (3nd
group) undergo only stent implantation into IRA the same day of STEMI.
Autologous BMMCs were obtained from bone marrow aspirate by gradient centrifugation.
Echocardiography, Holter monitoring were performed. Plasma concentration of the
pro-inflammatory and anti-inflammatory cytokines (IL1, 6,8,10), of the growth factors (stem
cell factor - SCF, vascular endothelial growth factor - VEGF, hepatocyte growth factor - HGF,
fibroblast growth factor - FGF, insulin-like growth factor - IGF), the number of circulating
CD34 +38-, CD133 +, СD117 +, CD90 +34- stem cells were determined in these patients in the
acute and sub-acute myocardial infarction period.
It is going 7 years after the beginning of planned to evaluate left ventricular function of
these patients, incidence of cardiovascular end points (death, recurrent myocardial
infarction, angina, heart failure, stroke) and their combinations, to evaluate the safety of
transplantation of autologous BMCs (formation of intra-myocardial tumor or neoplastic
processes of other sites) after 7 years from the beginning of study.
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