Japanese OMI Treatment With Kit-positive Cells for Enhanced Regeneration Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Monitoring adverse events
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.
详细描述
This phase I trial will involve 6 patients suffering from chronic ischemic cardiomyopathy and congestive heart failure, to be compared with historical control subjects. This study will be conducted as a collaborative project between the Sakakibara Heart Institute and the CellBank of Japan. The trial is designed to assess the safety and effectiveness of autologous administration of 1,000,000 c-kit-positive cardiac stem cells (CSCs) via intracoronary route following cultivation. The preliminary eligibility criteria will utilize a left ventricular ejection fraction (LVEF) less than 40% measured by echocardiography. During the coronary artery bypass grafting (CABG) surgery, a part (less than 1 gram) of the right atrial appendage (RAA) will be harvested and frozen. When the LVEF is less than 40% after the CABG surgery, the subject will be enrolled as a candidate for the delivery of CSCs, which will be selected from the RAA tissue and cultured for a few months for expansion. The outcome will be evaluated by adverse events as well as cardiac functions.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult with ability to provide informed consent.
- •Left ventricular ejection fraction less than 40% as evidenced by echocardiogram.
- •Scheduled for elective surgical revascularization within 2 months.
排除标准
- •Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis.
- •Diabetic HbA1c greater than 8.5%.
- •Pregnant women.
- •Scheduled for additional interventions including ventriculoplasty.
结局指标
主要结局
Monitoring adverse events
时间窗: 2 years
Including death, ventricular arrhythmia, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism
次要结局
- Serum NT-proBNP(2 years)
- NYHA classification(2 years)
- Chest X-ray(2 years)
- Echocardiogram(2 years)
- Electrocardiogram(2 years)
- Cardiopulmonary exercise test(2 years)
- Magnetic resonance imaging(2 years)
- Myocardial scintigraphy(2 years)