Clinical trial NCT01748383: 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)
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vascular Diseases
Cardiovascular Diseases
Acute Myocardial Infarction
Keywords: Bone marrow cells
Acute myocardial infarction
Transplantation of autologous mononuclear
Transplantation of autologous CD133 + cells
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular ejection fraction (Echo)
timeFrame: for an average of 7 years
Secondary outcomes:
measure: incidence of cardiovascular death
timeFrame: 7 years
measure: incidence of the recurrent myocardial infarction
timeFrame: 7 years
measure: incidence of the angina
timeFrame: 7 years
measure: incidence of the heart failure
timeFrame: 7 years
measure: incidence of the stroke
timeFrame: 7 years
measure: incidence of the combined endpoint
timeFrame: 7 years
measure: incidence and severity of adverse events
timeFrame: 7 years
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Scientific and Research Institution of Cardiology of Siberian Department of RAMS
Study officials:
affiliation: Scientific and Research Institution of Cardiology of Siberian Department of RAMS
name: Vyacheslav Ryabov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: