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)

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.

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).

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Vascular Diseases; Acute Myocardial Infarction
• Intervention / Treatment: Procedure: Transplantation of BMMCs; Procedure: Transplantation of CD 133+ cells; Procedure: stenting of IRA

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 Type: Interventional
• Enrollment (Anticipated): 85
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Tomsk, Russian Federation, 634012
    • Scientific and Research Institution of Cardiology of Siberian Department of RAMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Russian Academy of Medical Sciences
• Investigators: Principal Investigator: Vyacheslav Ryabov, MD, PhD, Scientific and Research Institution of Cardiology of Siberian Department of RAMS

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): September 1, 2014

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (ESTIMATE): December 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 13, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Acute myocardial infarction; Bone marrow cells; Transplantation of autologous mononuclear; Transplantation of autologous CD133 + cells
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Myocardial Infarction; Infarction; Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 99 (CTEP)