CLINICAL TRIALS

This information is provided for the purpose of objective disclosure regarding ongoing clinical trials and is not intended to solicit participation in any specific trial. Eligibility for participation is determined based on specific criteria, including medical condition (Inclusion/Exclusion Criteria). If you would like more details, please consult your primary care physician, who is familiar with your current health status.

Pediatric Patients With Single Ventricles

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. This study is being conducted solely within Japan.

Title

Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease

Purpose

To evaluate the efficacy and safety of intracoronary injection of JRM-001

Patients

Functional single ventricle patient with heart failure who is scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery

• 0 years to 6 years (child)
• Reduced cardiac function

Trial Design

Multicenter, randomized, participant and evaluator-blind, parallel assignment

Recruiting

Active

NCT#

NCT02781922