Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Intracoronary Transplantation in Myocardial Infarction and Other Heart Diseases.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Heart function
研究概览
简要总结
The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute Myocardial Infarction(within one month);
- •Age under 65;
- •Infarction related wall motion abnormality on echocardiography;
- •Infarction related TIMI flow grades 3 on coronary angiography during cell injection;
- •Informed consent;
排除标准
- •Active infection, or hematopoietic malignancy;
- •Patients have tumor or other lethal diseases;
- •Informed refusal
结局指标
主要结局
Heart function
时间窗: one year
次要结局
未报告次要终点