Trials / Recruiting
RecruitingNCT02781922
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Metcela Inc. · Industry
- Sex
- All
- Age
- 0 Years – 6 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Autologous cardiac stem cells (JRM-001) | 3x 10\^5 cells/kg, single treatment |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2016-05-25
- Last updated
- 2025-09-30
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02781922. Inclusion in this directory is not an endorsement.