HepaStem Long-Term Safety Registry

Acute on Chronic Liver Failure Clinical Trial

— PROLONGSTEM  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03343756
• Other study ID #: PROLONGSTEM
• Status: Enrolling by invitation
• Start date: April 4, 2018
• Est. completion date: July 2028

Study information

• Verified date: February 2024
• Source: Cellaion SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22
• Est. completion date: July 2028
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• Crigler-Najjar Syndrome
• End Stage Liver Disease
• Liver Failure
• Urea Cycle Disorder
• Urea Cycle Disorders, Inborn

Locations

Country	Name	City	State
Belgium	Hopital Erasme	Anderlecht
Belgium	Antwerp University Hospital	Antwerp
Belgium	UCL	Brussel
Belgium	Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHC MontLegia	Liège
Belgium	Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert
Bulgaria	University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD	Pleven
Bulgaria	UMHAT Medica Ruse	Ruse
Bulgaria	Military Medical Academy	Sofia
France	Centre Hospitalier Universitaire Amiens Picardie	Amiens
France	Centre Hospitalier Universitaire D'Angers	Angers
France	University Hospital Of Bordeaux	Bordeaux
France	CHU Lille	Lille
France	Hospices Civils De Lyon	Lyon
France	Assistance Publique Hopitaux De Marseille	Marseille
France	Centre Hospitalier Universitaire De Montpellier	Montpellier
France	Assistance Publique Hopitaux De Paris	Paris
France	Les Hopitaux Universitaires De Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse
France	Hopital Paul Brousse	Villejuif
Poland	Id Clinic	Myslowice
Spain	Hospital De La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario Ramon Y Cajal	Madrid
Spain	Parc Tauli Hospital Universitari	Sabadell
Spain	Hospital Unviersitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Cellaion SA

Countries where clinical trial is conducted

Belgium,  Bulgaria,  France,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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