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)

Phase 2

• Conditions: Vascular Diseases; Cardiovascular Diseases; Acute Myocardial Infarction
• Interventions: Procedure: stenting of IRA; Procedure: Transplantation of BMMCs; Procedure: Transplantation of CD 133+ cells

• Registration Number: NCT01748383
• Lead Sponsor: Russian Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2005-09
• Status Verified: 2012-12
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17
• Primary Completion: 2013-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stenting of IRA	stenting of IRA	The only stenting of IRA
Transplantation of BMMCs	Transplantation of BMMCs	Autologous BMCs aspiration and transplantation of these cells
Transplantation of CD 133+ cells	Transplantation of CD 133+ cells	Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction (Echo)	for an average of 7 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Scientific and Research Institution of Cardiology of Siberian Department of RAMS; 🇷🇺 Tomsk, Russian Federation