Clinical trial NCT03343756: HepaStem Long-Term Safety Registry
Official title: HepaStem Long-Term Safety Registry - Registry for Patients Who Have Been Administered HepaStem
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Urea Cycle Disorder
Crigler-Najjar Syndrome
Acute on Chronic Liver Failure
Lead sponsor: Cellaion SA
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 44
Sex: ALL
Minimum age (years): 5
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of Adverse Events of Specific Interest (AESI)
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Hopital Erasme
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
city: Brussels
country: Belgium
facility: Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
city: Brussel
country: Belgium
facility: UCL
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHC MontLegia
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
city: Ruse
country: Bulgaria
facility: UMHAT Medica Ruse
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Amiens
country: France
facility: Centre Hospitalier Universitaire Amiens Picardie
city: Angers
country: France
facility: Centre Hospitalier Universitaire D'Angers
city: Bordeaux
country: France
facility: University Hospital Of Bordeaux
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Hospices Civils De Lyon
city: Marseille
country: France
facility: Assistance Publique Hopitaux De Marseille
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire De Montpellier
city: Paris
country: France
facility: Assistance Publique Hopitaux De Paris
city: Strasbourg
country: France
facility: Les Hopitaux Universitaires De Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Villejuif
country: France
facility: Hopital Paul Brousse
city: Mysłowice
country: Poland
facility: Id Clinic
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Sabadell
country: Spain
facility: Parc Tauli Hospital Universitari
city: Zaragoza
country: Spain
facility: Hospital Unviersitario Miguel Servet
Study officials:
References: