NCT00507468已完成1 期
Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Safety of treatment
研究概览
简要总结
The object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the myocardium using the helical needle transendocardial (TE) delivery system in stable coronary patients with ventricular dysfunction due to chronic myocardial infarction (MI).
A secondary goal was to assess the possibility that such cell injections could improve ejection fraction (EF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be 18 years of age or older
- •Able to give informed consent
- •Must have documentation of prior myocardial infarction with left ventricular ejection fraction of less than 40 percent at baseline
- •Must be a candidate for percutaneous heart catheterization
- •Must have identifiable area of transmural scar within the left ventricle
排除标准
- •Be a candidate for concurrent ventricular surgical restoration, AICD placement or valvular surgery
- •Clinical evidence of infection
- •Other complicating cardiovascular abnormalities
- •Clinically significant electrocardiographic abnormalities
- •Active malignancy
- •Recent history or drug or alcohol abuse
- •Pregnancy, planned or current
- •Artificial aortic valve
- •Ejection fraction less than 30 percent at baseline
- •Myocardial infarction in the past 4 weeks
结局指标
主要结局
Safety of treatment
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (4)
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