jRCT1080223307招募中3 期
Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM- 001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Metcela Inc.
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Randomized, Standard-of-care Controlled, Single-blind, Parallel-group
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- No limit 至 6age old under（—）
- 性别
- All
入选标准
- •Main inclusion criteria:
- •Functional single ventricle patient who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery
- •Ejection fraction (%) by echocardiography =< 55%
排除标准
- •Main exclusion criteria:
- •Known medical history of cardiogenic shock
- •Lethal, uncontrollable arrhythmia
- •Complication of coronary artery disease
- •Eisenmenger syndrome
- •Complication of brain dysfunction due to circulatory failure
- •Malignant neoplasm
- •Complication of severe neurologic disorder
- •Severe pulmonary embolism or pulmonary hypertension
- •Severe renal failure
- •Multiple organ failure
- •Active infection (including endocarditis)
- •Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury)
结局指标
主要结局
-
efficacy confirmatory Ejection fraction assessed by cardiac MRI
次要结局
- Cardiac function
研究者
研究点 (1)
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