CLINICAL TRIALS

This page provides information about ongoing clinical trials and is not intended to solicit participation in any specific trial. Eligibility is determined by each trial’s inclusion and exclusion criteria, including requirements related to a patient’s medical condition. For more information, please consult your treating physician, who is familiar with your current health status.

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

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 a functional single ventricle. This study is being conducted solely within Japan.

Purpose

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

Patients

Patients with a functional single ventricle and heart failure who are scheduled for stage 2 (Glenn) or stage 3 (Fontan) surgery

• Ages 0–6 years
• Reduced cardiac function

Trial Design

Multicenter, randomized, participant- and evaluator-blinded, parallel-group study

Recruitment Status

Recruiting

NCT#

NCT02781922

Long-Term Safety Study Following JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease

This study is a follow-up study of pediatric patients with a functional single ventricle who participated in the “Efficacy and Safety Study of Autologous Cardiac Stem Cells (JRM-001) Treated After Reconstructive Surgery in Pediatric Patients With Congenital Heart Disease” (the “001 Study”). The study will monitor and evaluate safety through 24 months after JRM-001 treatment. This study is being conducted solely within Japan.

Purpose

To evaluate long-term safety through an additional one-year follow-up of patients who participated in the 001 Study

Patients

Patients who participated in the 001 Study are eligible if they either received JRM-001 treatment or underwent the corresponding cardiac catheterization as part of the non-treatment control group. Written informed consent for participation in this study must be provided by their legally authorized representative.

Trial Design

Multicenter, prospective, single-blind (participant-blinded), non-treatment-controlled study

Recruitment Status

Recruiting

NCT#

Registration in progress