Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)

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

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

Inclusion Criteria:

• 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

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)
• Sepsis
• 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