Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
NCT02781922 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-09-30
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
Conditions
- Hypoplastic Left Heart Syndrome
- Single Ventricle
Interventions
- GENETIC
-
Autologous cardiac stem cells (JRM-001)
3x 10\^5 cells/kg, single treatment
Sponsors & Collaborators
-
Metcela Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 0 Years
- Max Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-30
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
Countries
- Japan
Study Locations
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