Actively Recruiting
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Led by Metcela Inc. · Updated on 2025-09-30
40
Participants Needed
4
Research Sites
652 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery
- Ejection fraction (EF%) by echocardiography 55% or less
- Written informed consent obtained from a parent
You will not qualify if you...
- Known history of cardiogenic shock
- Lethal, uncontrollable arrhythmia
- Coronary artery disease
- Eisenmenger syndrome
- Brain dysfunction due to circulatory failure
- Malignant neoplasm
- Severe neurologic disorder
- Severe pulmonary embolism or pulmonary hypertension
- Severe renal failure
- Multiple organ failure
- Active infection including endocarditis
- Sepsis
- Active hemorrhagic disease such as gastrointestinal bleeding or injury
- Known hypersensitivity to anti-infective drugs
- Inability to complete treatment and follow-up examinations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Kanagawa Children's Medical Center
Kanagawa, Japan
Actively Recruiting
2
Okayama University Hospital
Okayama, Japan
Actively Recruiting
3
Saitama Prefectural Children's Medical Center
Saitama, Japan
Actively Recruiting
4
Shizuoka Children's Hospital
Shizuoka, Japan
Actively Recruiting
Research Team
M
Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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