Clinical Trials in Japan / NCT02781922
Recruiting
Phase 3
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
NCT02781922 · tracked via the Priya Life Science Japan tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Metcela Inc. trials in Japan
Other trials for the same condition
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