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)

Russian Academy of Medical Sciences (RAMS)

Status and phase: Unknown; Phase 2

Conditions: Cardiovascular Diseases; Acute Myocardial Infarction; Vascular Diseases

Treatments: Procedure: Transplantation of CD 133+ cells; Procedure: stenting of IRA; Procedure: Transplantation of BMMCs

Study type: Interventional

Funder types: Other

Identifiers

NCT01748383

99

Details and patient eligibility

About

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).

Full 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.

Enrollment: 85 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 3 patient groups

Transplantation of BMMCs

Experimental group

Description:

Autologous BMCs aspiration and transplantation of these cells

Treatment:

Procedure: Transplantation of BMMCs

Transplantation of CD 133+ cells

Experimental group

Description:

Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells

Treatment:

Procedure: Transplantation of CD 133+ cells

stenting of IRA

Active Comparator group

Description:

The only stenting of IRA

Treatment:

Procedure: stenting of IRA