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Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Sponsor: Metcela Inc.
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
Official title: Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease: A Multicenter Randomized Single-blind Parallel-group Study
Key Details
Gender
All
Age Range
0 Years - 6 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2016-06
Completion Date
2028-12
Last Updated
2025-09-30
Healthy Volunteers
No
Interventions
Autologous cardiac stem cells (JRM-001)
3x 10\^5 cells/kg, single treatment
Locations (4)
Kanagawa Children's Medical Center
Kanagawa, Japan
Okayama University Hospital
Okayama, Japan
Saitama Prefectural Children's Medical Center
Saitama, Japan
Shizuoka Children's Hospital
Shizuoka, Japan