Ireland
--:--IST
Recruiting Phase 3

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

NCT02781922 · tracked via the Priya Life Science Japan tracker
Sponsor
Metcela Inc
Phase
Phase 3
Started
2016-06
Last updated
2026-10-19

Condition(s) studied

Hypoplastic Left Heart SyndromeSingle Ventricle

Investigational drug(s) / intervention(s)

Autologous cardiac stem cells (JRM-001)

Autologous cardiac stem cells (JRM-001): 3x 10\^5 cells/kg, single treatment

Study 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

Sex
ALL
Min age
0 Years
Max age
6 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in ejection fraction (EF(%)) assessed by MRI from baseline — Baseline, 6 and 12 months

Trial sites (4)

FacilityCityRegionStatus
Kanagawa Children's Medical Center Kanagawa Japan Recruiting
Okayama University Hospital Okayama Japan Recruiting
Osaka Women's and Children's Hospital Osaka Japan Recruiting
Shizuoka Children's Hospital Shizuoka Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02781922 on ClinicalTrials.gov ↗ ← All trials in Japan