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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
3x 10\^5 cells/kg, single treatment
Kanagawa Children's Medical Center
Kanagawa, Japan
RECRUITINGOkayama University Hospital
Okayama, Japan
RECRUITINGSaitama Prefectural Children's Medical Center
Saitama, Japan
RECRUITINGChange in ejection fraction (EF(%)) assessed by MRI from baseline
Time frame: Baseline, 6 and 12 months
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Shizuoka Children's Hospital
Shizuoka, Japan
RECRUITING