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Safety of UCB-MNC Delivered into the Myocardium in HLHS Subjects

To determine the safety and feasibility of autologous umbilical cord blood-derived mononuclear cells delivered into the myocardium of the right ventricle during planned Stage II Glen surgical procedure for individuals with hypoplastic left heart syndrome.

Xeltis Bioabsorbable Pulmonary Valved Conduit Early Feasibility Study

To assess the survival rate of subjects at 6 and 12 months following implantation of the Bioabsorbable pulmonary valve conduit. To assess the rate of conduit failures at 6 months, requiring re-intervention or reoperation.