NCT00743639已完成2 期
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy: Randomized Clinical Trial
Instituto de Cardiologia do Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Increase of the ejection function of the left ventricle
研究概览
简要总结
This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis made at more than one year and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
- •Left ventricular ejection fraction (LVEF) less than 35% by echocardiogram
- •Age below 70 years
- •Absence of neoplasm
- •Abscence of hematologic disease or systemic disease
- •No previous cardiac intervention
排除标准
- •Episodes of tachycardia or ventricular fibrillation
- •Severe or moderated mitral insufficiency
- •Any other valvulopathies
- •Previous cardiac surgery
结局指标
主要结局
Increase of the ejection function of the left ventricle
时间窗: twelve months
次要结局
未报告次要终点
研究者
研究点 (2)
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