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RECRUITING
NCT02781922
PHASE3

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

Sponsor: Metcela Inc.

View on ClinicalTrials.gov

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

GENETIC

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