Acute on Chronic Liver Failure, Crigler-Najjar Syndrome, Urea Cycle Disorder
Conditions
Brief summary
All patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HHALPC during a previous interventional clinical study conducted by Promethera Biosciences
Interventions
None listed
Sponsors
Cellaion SA
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
5 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All patients having received at least one infusion of HepaStem during a previous interventional clinical study conducted by Promethera.
Exclusion criteria
* Patients who received an OLT and completed 6-month FU documentation prior to the start of the PROLONGSTEM study. * Patients who have received mature liver cells or stem cells other than HepaStem prior to the start of the PROLONGSTEM study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events of Specific Interest (AESI) | 60 months | Adverse Events of Specific Interest (AESI): * Event with fatal outcome (Death) * Orthotopic Liver Transplantation (OLT) and Outcome. * Development of Malignancy or unwanted tissue formation in different organs (tumor malignant or not). * Disease linked to transmission of adventitious agents or reactivation of latent pathogens. * Any AE which in the opinion of the Investigator has a plausible causal relationship to HepaStem. |
Countries
Belgium, Bulgaria, France, Poland, Spain
Outcome results
None listed