Effects and Mechanism of Autologous Bone Marrow Mononuclear Cells (BMMNC)Transplantation in Diabetic Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Who Have Undergone Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of patient death during the follow up period
研究概览
简要总结
The purpose of this study is to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone percutaneous coronary intervention (PCI).
详细描述
Stem cells are capable of the important properties of self-renewal and differentiation plasticity. Human autologous bone marrow mononuclear cells (BMMNC) contain CD34+ haematopoietic and CD34- mesenchymal stem cells. Both of these cell types may contribute to heart muscle repair in acute myocardial infarction (AMI). In recent years, a variety of clinical trials have explored the hypothesis that BMMNC transplantation may enhance the recovery of left ventricular function after AMI. The use of BMMNC is clinically justified and ethically unquestionable because no severe side effects have been reported and immunosuppressive therapy is unnecessary. More over, our previous work showed that patients without diabetes may benefit more from BMMNC transplantation. Thus, the aim of the present study was to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone PCI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 25 and 60 years old
- •STEMI according to the WHO definition
- •PCI <12 hours from the onset of symptoms
- •LAD disease with an open infarct related artery
排除标准
- •previous myocardial infarction (MI)
- •cardiomyopathy
- •atrial fibrillation or flutter
- •previous heart surgery
- •severe valvular heart disease
- •disease of the hematopoietic system
- •NYHA functional class IV heart failure at baseline
- •severe renal, lung and liver disease
- •intra-cardiac thrombus
- •bone marrow disease
结局指标
主要结局
Number of patient death during the follow up period
时间窗: 4years
Number of patient death during the follow up period as a measure of safety
次要结局
- Left ventricular ejection fraction(4 years)
- Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)(4 years)
- Scores on the Seattle angina questionnaire(4 years)
- six-min walk distance (6MWD)(4 years)
- Infarct size as evaluated by Single-photon emission computed tomography (SPECT)(4 years)
- Number of target vessel revascularization(4 years)
- Angina class according to the canadian cardiovascular society (CCS) classification(4 years)