HepaStem Long-Term Safety Registry

Cellaion SA44 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Urea Cycle Disorder Crigler-Najjar Syndrome Acute on Chronic Liver Failure

Eligibility

Sex: ALLMin age: 5 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (29)

Hopital Erasme

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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