Overview

This trial is active, not recruiting.

Conditions vascular diseases, cardiovascular diseases, acute myocardial infarction
Treatments transplantation of bmmcs, transplantation of cd 133+ cells, stenting of ira
Phase phase 2
Sponsor Russian Academy of Medical Sciences
Start date September 2005
End date September 2013
Trial size 85 participants
Trial identifier NCT01748383, 99

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Autologous BMCs aspiration and transplantation of these cells
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)
Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells
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)
The only stenting of IRA
stenting of ira
The only stent implantation

Primary Outcomes

Measure
Left ventricular ejection fraction (Echo)
time frame: for an average of 7 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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.
Principal investigator Vyacheslav Ryabov, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Russian Academy of Medical Sciences.