The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells (BMCs) in Patients With the First STEMI (ST Segment Elevation Myocardial Infarction)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Vascular Diseases, Cardiovascular Diseases, Acute Myocardial Infarction

Intervention / Treatment
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* Procedure: Transplantation of BMMCs
* Procedure: Transplantation of CD 133+ cells
* Procedure: stenting of IRA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transplantation of BMMCs<br>Autologous BMCs aspiration and transplantation of these cells | Procedure: Transplantation of BMMCs<br>* 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.<br>|
| Experimental: Transplantation of CD 133+ cells<br>Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells | Procedure: Transplantation of CD 133+ cells<br>* 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.<br>|
| Active Comparator: stenting of IRA<br>The only stenting of IRA | Procedure: stenting of IRA<br>* The only stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (Echo) |  | for an average of 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of cardiovascular death |  | 7 years | 
| incidence of the recurrent myocardial infarction |  | 7 years | 
| incidence of the angina |  | 7 years | 
| incidence of the heart failure |  | 7 years | 
| incidence of the stroke |  | 7 years | 
| incidence of the combined endpoint |  | 7 years | 
| incidence and severity of adverse events |  | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow cells, Acute myocardial infarction, Transplantation of autologous mononuclear, Transplantation of autologous CD133 + cells