The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II Bidirectional Cavopulmonary Anastomosis (BDCPA) operation and to observe effects on clinical outcome including right ventricular myocardial function, severity of tricuspid regurgitation, incidence of serious adverse events, re-hospitalizations, changes in health status, the need for transplantation, or mortality.
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Number of Incidence of Treatment Related Major Adverse Cardiac Events
Timeframe: 30 days
Number of C-kit+ Products
Timeframe: Day 1
Number of Participants Completing Magnetic Resonance Imaging (MRI)
Timeframe: Baseline, 6 Months, 12 months
Change in Right Ventricular Function (RVEF)
Timeframe: Baseline, 6 Months, 12 months
Change in Right Ventricular End-diastolic Volume (RVEDV)
Timeframe: Baseline, 6 months, 12 months
Change in Right Ventricular End-systolic Volume (RVESV)
Timeframe: Baseline, 6 months, 12 months
Change in Tricuspid Regurgitation
Timeframe: Baseline, 6 months, 12 months