Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The aim of the study is to investigate whether infusion of autologous bone marrow derived stem cells can improve cardiac function in the aftermath of a myocardial infarction.
详细描述
Primary coronary intervention within a few hours of a myocardial infarction has greatly reduced mortality as well as the risk of developing chronic heart failure. There are though still a large number of patients that develop symptoms of heart failure in the form of fatigue and breathlessness with physical exertion in spite of medical treatment. With the advance in stem cell technology there is now hope for the possibility of regenerating/repairing dead myocardial tissue, hence improving cardiac function.
The current study is a pilot study that is going to precede a later double blinded randomized study. The aim of the study is to evaluate patient safety, optimize procedures, and to be used in power calculation in the design of the following study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chestpain
- •Troponin T, > 0,1ng/ml
- •Succesfull revascularization of culprit lesion with PCI.
- •No more than stenosis of 2 major epicardiel coronary arteries.
排除标准
- •Cardiogenic shock
- •Known LVEF<45%
- •Cardiomyopathy
- •Atrialfibrillation or fluctuation
- •Takyarytmia
- •Infection
- •Chronic inflammatory disease
结局指标
主要结局
Safety
次要结局
- Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography