TerminatedNot Applicable

HepaStem Long-Term Safety Registry

Stopped: Sponsor decision related to product development prioritisation.

Belgium44 participantsStarted 2018-04-04

Plain-language 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

Who can participate

Age range5 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Occurrence of Adverse Events of Specific Interest (AESI)

Timeframe: 60 months

Trial details

NCT IDNCT03343756

SponsorCellaion SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-05-23

View on ClinicalTrials.gov More Urea Cycle Disorder trials