Stem Cell Therapy in Chronic Ischemic Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
研究概览
简要总结
The purpose of this study is to determine whether intracoronary bone marrow transplantation can improve left ventricular ejection fraction in patients with severe ischemic heart failure and no other option for standard therapies (revascularization and drugs).
详细描述
Despite standard therapies (revascularization and drugs), patients with severe ischemic heart failure have a high morbidity and mortality.
The purpose of this study is to determine whether intracoronary transfer of autologous bone marrow cells can induce angiogenesis, subsequently improving regional myocardial perfusion, and finally resulting in improved systolic and diastolic left ventricular function in patients with severe ischemic heart failure.
35 patients with stable left ventricle function will - with four months interval - receive two treatments with bone marrow transplantation intracoronary in vessels supplying dysfunctional myocardial territories. Echocardiography is performed three times prior (four and two months and just before) and two times after (four and eight months after) therapy. It is a non-randomised trial, patients will enter as their own control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe ischemic heart failure and no other other option for standard therapies (revascularization and drugs),
- •Stable left ventricular ejection fraction < 40%,
- •CCS class 2-3 and/or NYHA class 2-3, and
- •Signed informed consent.
排除标准
- •Implantation of pacemaker (including implantable cardioverter defibrillator [ICD] and biventricular pacing),
- •Acute myocardial infarction within 3 months,
- •Atrial fibrillation, or
- •Severe comorbidity that could impact the patient's short-term survival (including primary hematologic disorders)
结局指标
主要结局
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
次要结局
未报告次要终点