NCT00933621已完成2 期
Intracoronary Injection of Autologous Bone Marrow Cells in Patients With Chronic Heart Failure: Five Years Follow up
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Procedure success
研究概览
简要总结
The study aim is to evaluate the long term outcome of intra-coronary autologous bone marrow (BM) transplantation in patients with severe ischemic cardiomyopathy without the option for revascularization.
详细描述
Several studies have demonstrated the short term safety, feasibility and efficacy of cell transplantation in patients with advanced heart failure. There are no data about the long term outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with evidence of hibernation and/or ischemia in at least 2 different myocardial segments underwent coronary angiography
排除标准
- •Idiopathic or non-ischemic cardiomyopathy
- •Other etiology for heart failure, history of past or current disease involving the bone marrow
- •Patients on dialysis
- •Positive serologic test for HIV, hepatitis B or C or any neoplastic or terminal disease
结局指标
主要结局
Procedure success
时间窗: 9 months
次要结局
- Functional class improvement(9 months)
研究者
研究点 (2)
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