Crigler-Najjar (CN) and Fibroinflammatory liver diseases., This study will include all patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HALPC during a previous interventional clinical study conducted by Promethera Biosciences or Promethera Therapeutics including patients suffering from urea cycle disorders (UCD)
Conditions
Brief summary
To document the occurrence of adverse events of special interest (AESIs) as defined below: • Event with fatal outcome (death) • Organ transplantation and outcome • Development of malignancy or unwanted tissue formation in different organs (tumor development malignant or not) • Disease linked to transmission of adventitious agents or reactivation of latent pathogens • Any adverse event (AE) judged to have a plausible causal relationship to HepaStem.
Interventions
DRUGHepaStem
Sponsors
Cellaïon SA
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To document the occurrence of adverse events of special interest (AESIs) as defined below: • Event with fatal outcome (death) • Organ transplantation and outcome • Development of malignancy or unwanted tissue formation in different organs (tumor development malignant or not) • Disease linked to transmission of adventitious agents or reactivation of latent pathogens • Any adverse event (AE) judged to have a plausible causal relationship to HepaStem. | — |
Countries
Belgium, Bulgaria, France, Poland, Spain
Outcome results
None listed