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

Metcela

Status and phase

Enrolling

Phase 3

Conditions

Single Ventricle

Hypoplastic Left Heart Syndrome

Treatments

Genetic: Autologous cardiac stem cells (JRM-001)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02781922

001-CLJ-001

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

All

Ages

Under 6 years old

Volunteers

No Healthy Volunteers

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