Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- LV function (Ejection fraction within 3 months) Simpson
研究概览
简要总结
Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with non ischemic dilated cardiomyopathy.
详细描述
Initial clinical pilot trials suggested that intracoronary infusion of bone marrow-derived progenitor cells (BMC) may enhance left ventricular functional recovery in patients with acute myocardial infarction. It is unknown, however, whether such a strategy might also be applicable to patients with non-ischemic dilated cardiomyopathy (DCM). Therefore, we initiated the TOPCARE-DCM - trial (Transplantation Of Progenitor Cells And Recovery of Left Ventricular Function in Patients with non ischemic Dilatative CardioMyopathy) aiming to regionally improve left ventricular contractility by selective infusion of BMC into the left anterior descending coronary artery.
Patients will be randomized 2:1 (20/10) BMC Infusion versus standard medical therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dilated Cardiomyopathy, Ejection fraction < 40%
- •LVEDD > 60mm
- •Stable clinical condition within last 6 months
- •Written informed consent
排除标准
- •Myocardial infarction or coronary intervention in the past
- •Change of medical therapy within the last 6 weeks prior to cell therapy
- •Tumor within last 5 years or incomplete remission
- •Active infection
- •Active bleeding
- •Stroke within last 2 years
- •Surgery or trauma within last 2 months
- •Uncontrolled hypertension
- •HIV infection
- •Chronic inflammatory disease
- •Liver disease (GOT > 2x upper normal limit)
- •Renal dysfunction (creatinin > 2.0mg/dl)
- •Thrombopenia < 100.000
- •Anemia (hemoglobin < 8.5 g/dl)
- •Mental retardation
结局指标
主要结局
LV function (Ejection fraction within 3 months) Simpson
时间窗: 4 months
次要结局
未报告次要终点