Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Open Label, Multicenter, Partially Randomized, Safety Study of One Cycle of Promethera HepaStem in Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (C
Brief Summary:
The purpose of this study is to assess the safety and to appraise the efficacy of one cycle of Hepastem (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC) infusions in paediatric patients suffering from CN or UCD.
The study duration: 12 months starting from the day of treatment: 6 months active surveillance and 6 months observation post-infusion.