NCT00612911终止不适用
Cell Therapy in Dilated Cardiomyopathy: A Safety and Feasibility Study Using Autologous Bone Marrow Mononuclear Cells
Ministry of Health, Brazil1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2005年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- echocardiography
研究概览
简要总结
Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy
详细描述
Patients with Idiopathic dilated cardiomyopathy class II to IV NYHA with ejection fraction <35% were selected for phase I clinical trial of bone marrow mononuclear cell delivery in the coronary arteries and followed for 6 months
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic dilated cardiomyopathy
- •Optimized therapy and for idiopathic dilated cardiomyopathy
- •Left ventricular ejection fraction (Simpson) < 35%
- •Peak oxygen consumption (VO2 peak) < 16 mL.kg-1min-1
- •Functional classes II-IV of the NYHA
排除标准
- •dilated cardiopathies of ischemic or chagasic origin
- •primary valve disease
- •excessive use of alcohol or illicit drugs
- •pregnancy
- •ventricular arrhythmias
- •any co-morbidity with impact on survival
结局指标
主要结局
echocardiography
时间窗: 2 months
次要结局
未报告次要终点
研究者
研究点 (1)
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