HepaStem Long-Term Safety Registry (PROLONGSTEM)

HepaStem Long-Term Safety Registry - Registry for Patients Who Have Been Administered HepaStem

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 Overview

• Status: Enrolling by invitation
• Conditions: Urea Cycle Disorder; Crigler-Najjar Syndrome; Acute on Chronic Liver Failure

• Study Type: Observational
• Enrollment (Estimated): 22

Contacts and Locations

Study Locations

• Belgium
  • Anderlecht, Belgium, 1070
    • Hôpital Erasme
  • Antwerp, Belgium, 2650
    • Antwerp University Hospital
  • Brussel, Belgium, 1200
    • UCL
  • Brussels, Belgium, 1020
    • Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • Chc Montlegia
  • Woluwe-Saint-Lambert, Belgium
    • Cliniques Universitaires Saint-Luc
• Bulgaria
  • Pleven, Bulgaria, 5803
    • University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
  • Ruse, Bulgaria, 7013
    • UMHAT Medica Ruse
  • Sofia, Bulgaria, 1606
    • Military Medical Academy
• France
  • Amiens, France, 80080
    • Centre Hospitalier Universitaire Amiens Picardie
  • Angers, France, 49933
    • Centre Hospitalier Universitaire d'Angers
  • Bordeaux, France, 33608
    • University Hospital of Bordeaux
  • Lille, France, 59037
    • CHU Lille
  • Lyon, France, 69317
    • Hospices Civils de Lyon
  • Marseille, France, 13005
    • Assistance Publique Hopitaux de Marseille
  • Montpellier, France, 34295
    • Centre Hospitalier Universitaire de Montpellier
  • Paris, France, 75013
    • Assistance Publique Hopitaux De Paris
  • Strasbourg, France, 67000
    • Les Hôpitaux Universitaires de Strasbourg
  • Toulouse, France, 31059
    • CHU Toulouse
  • Villejuif, France, 94804
    • Hopital Paul Brousse
• Poland
  • Mysłowice, Poland, 41-400
    • ID Clinic
• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 8035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28049
    • Hospital Universitario Ramon Y Cajal
  • Sabadell, Spain, 08208
    • Parc Taulí Hospital Universitari
  • Zaragoza, Spain, 50009
    • Hospital Unviersitario Miguel Servet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 months

Collaborators and Investigators

• Sponsor: Cellaion SA

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Liver Failure, Acute; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Brain Diseases, Metabolic; Brain Diseases, Metabolic, Inborn; Amino Acid Metabolism, Inborn Errors; Hyperbilirubinemia, Hereditary; End Stage Liver Disease; Liver Failure; Acute-On-Chronic Liver Failure; Urea Cycle Disorders, Inborn; Crigler-Najjar Syndrome
• Other Study ID Numbers: PROLONGSTEM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No