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.
试验速览
- 阶段
- 2 期
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction (Echo)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Atrial fibrillation, a permanent form Valvular heart disease
- •Severe comorbidity
结局指标
主要结局
Left ventricular ejection fraction (Echo)
时间窗: for an average of 7 years
次要结局
- 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)
研究者
Vyacheslav Ryabov
Leading researcher of Emergency Cardiology Department
Russian Academy of Medical Sciences