RecruitingPhase 3NCT02781922

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


Sponsor

Metcela Inc.

Enrollment

40 participants

Start Date

Jun 1, 2016

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 0 YearsMax Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Autologous cardiac stem cells (JRM-001) for people with hypoplastic left heart syndrome and single ventricle. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 0 Years to 6 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICAutologous cardiac stem cells (JRM-001)

3x 10\^5 cells/kg, single treatment


Locations(4)

Kanagawa Children's Medical Center

Kanagawa, Japan

Okayama University Hospital

Okayama, Japan

Saitama Prefectural Children's Medical Center

Saitama, Japan

Shizuoka Children's Hospital

Shizuoka, Japan

View Full Details on ClinicalTrials.gov

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NCT02781922


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