RecruitingPhase 3NCT02781922

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

Sponsor

Metcela Inc.

Enrollment

40 participants

Start Date

Jun 1, 2016

Study Type

INTERVENTIONAL

Conditions

Hypoplastic Left Heart Syndrome Single Ventricle

Summary

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

Eligibility

Min Age: 0 YearsMax Age: 6 Years

Inclusion Criteria3

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 Criteria15

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