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PROLONGSTEM: HepaStem Long-Term Safety Registry

Sponsor
Promethera Therapeutics (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03343756
Collaborator
(none)
22
Enrollment
5
Locations
122.9
Anticipated Duration (Months)
4.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    22 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    HepaStem Long-Term Safety Registry - Registry for Patients Who Have Been Administered HepaStem
    Actual Study Start Date :
    Apr 4, 2018
    Anticipated Primary Completion Date :
    Jul 1, 2028
    Anticipated Study Completion Date :
    Jul 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCL Brussel Belgium 1200
    2 UZ Leuven Leuven Belgium 3000
    3 CHU Lille Lille France 59037
    4 CHU Toulouse Toulouse France 31059
    5 Hospital de Badajoz Badajoz Spain 06010

    Sponsors and Collaborators

    • Promethera Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Promethera Therapeutics
    ClinicalTrials.gov Identifier:
    NCT03343756
    Other Study ID Numbers:
    • PROLONGSTEM
    First Posted:
    Nov 17, 2017
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Failure
    End Stage Liver Disease
    Acute-On-Chronic Liver Failure
    Urea Cycle Disorders, Inborn
    Crigler-Najjar Syndrome

    Study Results

    No Results Posted as of Jan 14, 2022