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

NCT02781922 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-30

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781922 on ClinicalTrials.gov