Acute Myocardial Infarction, Cardiovascular Diseases, Vascular Diseases
Conditions
Keywords
Bone marrow cells, Acute myocardial infarction, Transplantation of autologous mononuclear, Transplantation of autologous CD133 + cells
Brief summary
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).
Detailed description
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.
Interventions
PROCEDURETransplantation of BMMCs
The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. BMMCs were obtained by the method of the gradient centrifugation. Autologous BMMCs in the number 93±43 million transplantation by balloon catheter performed into IRA at once after stent implantation.
PROCEDURETransplantation of CD 133+ cells
The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. Autologous CD133 + cells were obtained by the method of the magnetic separation. Phenotyping of the transplanted cells was performed by the cytofluorimetry. Autologous CD 133+ BMCs in the number 5,7 (0,45;9,0) million transplantation by balloon catheter performed into IRA at once after stent implantation.
PROCEDUREstenting of IRA
The only stent implantation
Sponsors
Russian Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 years and to 75 Years * Informed consent * First STEMI * Term admission to an intensive care unit in the first 24 hours of onset * Time reperfusion of the IRA is not earlier than 4 hours after the initial onset of acute transmural myocardial infarction
Exclusion criteria
* Atrial fibrillation, a permanent form Valvular heart disease * Severe comorbidity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction (Echo) | for an average of 7 years |
Secondary
| Measure | Time frame |
|---|---|
| incidence of the recurrent myocardial infarction | 7 years |
| incidence of the angina | 7 years |
| incidence of the heart failure | 7 years |
| incidence of cardiovascular death | 7 years |
| incidence of the combined endpoint | 7 years |
| incidence and severity of adverse events | 7 years |
| incidence of the stroke | 7 years |
Countries
Russia
Outcome results
None listed