Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
GENERAL:
MAIN INCLUSION CRITERIA
Crigler-Najjar Syndrome specific:
Diagnosis must be confirmed by genetic mutation analysis if not available.
Urea Cycle Disorders specific:
MAIN EXCLUSION CRITERIA
Primary purpose
Allocation
Interventional model
Masking
20 participants in 3 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal