An observational study in Urea Cycle Disorder, Crigler-Najjar Syndrome and Acute on Chronic Liver Failure, sponsored by Cellaion SA. Terminated at 29 sites in 5 countries. Open to participants aged 5 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Cellaion SA · Observational
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
66 studies on the registry are indexed under Urea Cycle Disorders, Inborn; 14 are open to participants now.
This study's enrollment of 44 is close to the median of 46 across 23 observational studies indexed under Urea Cycle Disorders, Inborn.
Browse Urea Cycle Disorders, Inborn studies →Cellaion SA is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who received HepaStem in the interventional studies conducted by Promethera will be proposed to participate in this PROLONGSTEM study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Occurrence of Adverse Events of Specific Interest (AESI)
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.
Time frame: 60 months
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Urea Cycle Disorders, Inborn →
Cellaion SA