JPRN-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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 6age old（—）
- 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)
研究者
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