Clinical Trial: Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Par
Brief 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
Detailed Summary:
Sponsor: Japan Regenerative Medicine Co., Ltd.
Current Primary Outcome: Change in ejection fraction (EF(%)) assessed by MRI from baseline [ Time Frame: Baseline, 6 and 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in EF(%) assessed by echocardiograms from baseline [ Time Frame: Screening, Baseline, 3, 6 and 12 months ]
- Change in EF(%) assessed by cardiac catheterization from baseline [ Time Frame: Baseline, 6 and 12 months ]
- Change in Ea/Ees assessed by cardiac catheterization from baseline [ Time Frame: Baseline, 6 and 12 months ]
- Change in Ventricular Stiffness assessed by cardiac catheterization from baseline [ Time Frame: Baseline, 6 and 12 months ]
- Change in heart failure index from baseline [ Time Frame: Baseline, 3, 6 and 12 months ]
- Change in Quality of Life (QOL) index from baseline [ Time Frame: Baseline, 6 and 12 months ]
- Number of adverse events [ Time Frame: Up to 12 months ]
Original Secondary Outcome: Same as current
Information By: Japan Regenerative Medicine Co., Ltd.
Dates:
Date Received: May 19, 2016
Date Started: June 2016
Date Completion: July 2018
Last Updated: August 4, 2016
Last Verified: June 2016
