NCT02781922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: A Multicenter Randomized Single-blind Parallel-group Study
适应症
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
- 4
- 主要终点
- Change in ejection fraction (EF(%)) assessed by MRI from baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 0 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery
- •EF(%) by echocardiography ≤ 55%
- •Able to obtain written informed consent of participation in the study by a parent of the patient
排除标准
- •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)
- •Known history of hypersensitivity to anti-infective drugs
- •Inability to complete the protocol treatment and baseline to follow-up examinations
结局指标
主要结局
Change in ejection fraction (EF(%)) assessed by MRI from baseline
时间窗: Baseline, 6 and 12 months
次要结局
- Change in EF(%) assessed by cardiac catheterization from baseline(Baseline, 6 and 12 months)
- Change in Ea/Ees assessed by cardiac catheterization from baseline(Baseline, 6 and 12 months)
- Change in EF(%) assessed by echocardiograms from baseline(Screening, Baseline, 3, 6 and 12 months)
- Change in heart failure index from baseline(Baseline, 3, 6 and 12 months)
- Change in Quality of Life (QOL) index from baseline(Baseline, 6 and 12 months)
- Number of adverse events(Up to 12 months)
- Change in Ventricular Stiffness assessed by cardiac catheterization from baseline(Baseline, 6 and 12 months)
研究者
研究点 (4)
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