A Prospective Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs.
研究概览
简要总结
A phase 1 prospective study to determine the procedural feasibility and safety and preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in patients with dilated cardiomyopathy.
详细描述
Five consecutive patients will be enrolled to a phase 1 study to verify the procedural feasibility and safety with the CDC infusion group.
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as dilated cardiomyopathy.
- •Patients aged under 18 years old.
- •Cardiac ejection fraction < 40%.
排除标准
- •Contradiction to cardiac magnetic resonance imaging.
- •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 a 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
Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs.
时间窗: 6 months after CDC treatment
Assessment of major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, acute coronary syndrome, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.
次要结局
- Change in Ejection Fraction(6 months after protocol treatment)
研究者
Hidemasa Oh, MD
Professor
Okayama University