HepaStem Long-Term Safety Registry

NCT03343756 | Terminated

• 1 other identifier: PROLONGSTEM
• Study Type: observational
• Target: 44
• Locations: 5 countries
• Sites: 29

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients having received at least one infusion of HepaStem during a previous interventional clinical study conducted by Promethera.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cellaion SA: lead

Study Sites (29)

Hopital Erasme

Anderlecht, 1070, Belgium

Location

Antwerp University Hospital

Antwerp, 2650, Belgium

Location

Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann

Brussels, 1020, Belgium

Location

UCL

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHC MontLegia

Liège, 4000, Belgium

Location

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

Location

University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD

Pleven, 5803, Bulgaria

Location

UMHAT Medica Ruse

Rousse, 7013, Bulgaria

Location

Military Medical Academy

Sofia, 1606, Bulgaria

Location

Centre Hospitalier Universitaire Amiens Picardie

Amiens, 80080, France

Location

Centre Hospitalier Universitaire D'Angers

Angers, 49933, France

Location

University Hospital Of Bordeaux

Bordeaux, 33608, France

Location

CHU Lille

Lille, 59037, France

Location

Hospices Civils De Lyon

Lyon, 69317, France

Location

Assistance Publique Hopitaux De Marseille

Marseille, 13005, France

Location

Centre Hospitalier Universitaire De Montpellier

Montpellier, 34295, France

Location

Assistance Publique Hopitaux De Paris

Paris, 75013, France

Location

Les Hopitaux Universitaires De Strasbourg

Strasbourg, 67000, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

Id Clinic

Mysłowice, 41-400, Poland

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 8035, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28009, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28049, Spain

Location

Parc Tauli Hospital Universitari

Sabadell, 08208, Spain

Location

Hospital Unviersitario Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Urea Cycle Disorders, Inborn; Crigler-Najjar Syndrome; Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperbilirubinemia, Hereditary; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: April 4, 2018
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

BU (3); ES (6); PL (1); FR (11); BE (8)