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) (ESTABOMA)
Recruitment status was: Active, not recruiting
|Vascular Diseases Cardiovascular Diseases Acute Myocardial Infarction||Procedure: Transplantation of BMMCs Procedure: Transplantation of CD 133+ cells Procedure: stenting of IRA||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Left ventricular ejection fraction (Echo) [ Time Frame: for an average of 7 years ]
- incidence of cardiovascular death [ Time Frame: 7 years ]
- incidence of the recurrent myocardial infarction [ Time Frame: 7 years ]
- incidence of the angina [ Time Frame: 7 years ]
- incidence of the heart failure [ Time Frame: 7 years ]
- incidence of the stroke [ Time Frame: 7 years ]
- incidence of the combined endpoint [ Time Frame: 7 years ]
- incidence and severity of adverse events [ Time Frame: 7 years ]
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Transplantation of BMMCs
Autologous BMCs aspiration and transplantation of these cells
Procedure: Transplantation 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.
Experimental: Transplantation of CD 133+ cells
Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells
Procedure: Transplantation 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.
Active Comparator: stenting of IRA
The only stenting of IRA
Procedure: stenting of IRA
The only stent implantation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748383
|Scientific and Research Institution of Cardiology of Siberian Department of RAMS|
|Tomsk, Russian Federation, 634012|
|Principal Investigator:||Vyacheslav Ryabov, MD, PhD||Scientific and Research Institution of Cardiology of Siberian Department of RAMS|