Phase 2 Study of Intracoronary Infusion of Cardiac Progenitor Cells in Patients With Univentricular Heart Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Cardiac function
研究概览
简要总结
The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease. Patients with preoperative high-risk group or whose cardiac function did not recover postoperatively eventually have no choice other than heart transplantation.
详细描述
Following the safety verification of the Phase I study (TICAP trial) that has been implemented and completed, the efficacy will be verified in this Phase II clinical study. The rationale of this study is based on the animal studies that transplanted cardiac progenitor cells may regenerate damaged myocardium by giving rise to cardiac muscle and vascular cell types. Preclinical and phase I studies indicate the possibilities of cardiac function improvements and reduced myocardial fibrosis by progenitor cell infusion.
The efficacy of cell transplantation is assessed as the primary endpoint of the Phase II clinical study. The improvements of cardiac ejection fraction assessed by echocardiography, ventriculography, and cardiac MRI, which are conducted before and after treatment, are assessed as the evaluation items. The absolute values of the improvement of cardiac ejection fraction obtained by the above three imaging modalities before and after treatment are compared between two groups of the transplantation group and non-transplantation group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Age is 0 year or more and 20 years or less at the time of enrollment.
- •The patients have functional single ventricular physiology with the indication to have stage-2 or -3 palliative surgeries.
- •The ventricular ejection fraction <60%.
排除标准
- •Cardiogenic shock
- •A patient with unstoppable extracorporeal circulation
- •A patient with lethal, uncontrollable arrhythmia
- •A patient with a complication of coronary artery disease
- •A patient with a complication of brain dysfunction due to circulatory failure
- •A patient with malignant neoplasm
- •A patient with a complication of serious neurologic disorder
- •A patient with high-grade pulmonary embolism or pulmonary hypertension
- •A patient with high-grade renal failure
- •A patient with multiple organ failure
- •Active infection (including endocarditis)
- •Active hemorrhagic disease (e. g. gastrointestinal bleeding, injury)
结局指标
主要结局
Cardiac function
时间窗: 3 Months
The primary outcome measure is to evaluate the cardiac function improvement by echocardiography, ventriculography, and cardiac MRI, which are conducted before and 3 months after surgical treatment.
次要结局
- Cardiac function(12 Months)
研究者
Hidemasa Oh, MD
Professor
Okayama University