Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Recruiting now · Phase 3
Conditions studied: Hypoplastic Left Heart Syndrome, Single Ventricle
In brief
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
Key facts
- Study ID
- NCT02781922
- Run by
- Metcela Inc.
- People needed
- 40
- Starts
- 2016-06-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2025-09-30
Who can join
Age: any, up to 6. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Kanagawa Children's Medical Center — Kanagawa, Japan (enrolling)
- Okayama University Hospital — Okayama, Japan (enrolling)
- Saitama Prefectural Children's Medical Center — Saitama, Japan (enrolling)
- Shizuoka Children's Hospital — Shizuoka, Japan (enrolling)
Full record on ClinicalTrials.gov
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