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
Patients who received HepaStem in the interventional studies conducted by Promethera will be proposed to participate in this PROLONGSTEM study.
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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Cellaion SA