HepaStem Long-Term Safety Registry

Terminated

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

• Registration Number: NCT03343756
• Lead Sponsor: Cellaion SA

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-17
• Study Start: 2018-04-04
• Status Verified: 2024-05
• Primary Completion: 2024-05-23
• Study Completion: 2024-05-23
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (29)

CHC MontLegia; 🇧🇪 Liège, Belgium

Centre Hospitalier Universitaire Amiens Picardie; 🇫🇷 Amiens, France

UCL; 🇧🇪 Brussel, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Hospices Civils De Lyon; 🇫🇷 Lyon, France

Hospital General Universitario Gregorio Maranon; 🇪🇸 Madrid, Spain

Hospital De La Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Ramon Y Cajal; 🇪🇸 Madrid, Spain

Hospital Unviersitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Parc Tauli Hospital Universitari; 🇪🇸 Sabadell, Spain

Assistance Publique Hopitaux De Marseille; 🇫🇷 Marseille, France

University Hospital Of Bordeaux; 🇫🇷 Bordeaux, France

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris, France

CHU Toulouse; 🇫🇷 Toulouse, France

Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann; 🇧🇪 Brussels, Belgium

Military Medical Academy; 🇧🇬 Sofia, Bulgaria

Hopital Erasme; 🇧🇪 Anderlecht, Belgium

University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD; 🇧🇬 Pleven, Bulgaria

UMHAT Medica Ruse; 🇧🇬 Ruse, Bulgaria

Centre Hospitalier Universitaire D'Angers; 🇫🇷 Angers, France

Hopital Paul Brousse; 🇫🇷 Villejuif, France

Cliniques Universitaires Saint-Luc; 🇧🇪 Woluwe-Saint-Lambert, Belgium

CHU Lille; 🇫🇷 Lille, France

Centre Hospitalier Universitaire De Montpellier; 🇫🇷 Montpellier, France

Les Hopitaux Universitaires De Strasbourg; 🇫🇷 Strasbourg, France

Id Clinic; 🇵🇱 Mysłowice, Poland