HepaStem Long-Term Safety Registry

NCT03343756 — Terminated, 44 participants, Cellaion SA

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT03343756, acronym PROLONGSTEM
StatusTerminated - Sponsor decision related to product development prioritisation.
Study typeObservational
Enrollment44 (Actual)
SponsorCellaion SA (Industry)
ConditionsUrea Cycle Disorder, Crigler-Najjar Syndrome, Acute on Chronic Liver Failure
Datesstart 2018-04-04, primary completion 2024-05-23, completion 2024-05-23, first posted 2017-11-17, last updated 2024-05-29
Locations29 sites in Belgium, Bulgaria, France, Poland, Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Urea Cycle Disorder All trials for Crigler-Najjar Syndrome

-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

Expand all sections  ·  Collapse all

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 5 Years to 75 Years

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.

+Locations (29)

FacilityCityCountryStatus
Hopital ErasmeAnderlechtBelgium
Antwerp University HospitalAntwerpBelgium
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire BrugmannBrusselsBelgium
UCLBrusselsBelgium
Universitair Ziekenhuis GentGhentBelgium
UZ LeuvenLeuvenBelgium
CHC MontLegiaLiègeBelgium
Cliniques Universitaires Saint-LucWoluwe-Saint-LambertBelgium
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EADPlevenBulgaria
UMHAT Medica RuseRousseBulgaria
Military Medical AcademySofiaBulgaria
Centre Hospitalier Universitaire Amiens PicardieAmiensFrance
Centre Hospitalier Universitaire D'AngersAngersFrance
University Hospital Of BordeauxBordeauxFrance
CHU LilleLilleFrance
Hospices Civils De LyonLyonFrance
Assistance Publique Hopitaux De MarseilleMarseilleFrance
Centre Hospitalier Universitaire De MontpellierMontpellierFrance
Assistance Publique Hopitaux De ParisParisFrance
Les Hopitaux Universitaires De StrasbourgStrasbourgFrance
CHU ToulouseToulouseFrance
Hopital Paul BrousseVillejuifFrance
Id ClinicMysłowicePoland
Hospital De La Santa Creu I Sant PauBarcelonaSpain
Hospital Universitari Vall D'HebronBarcelonaSpain
Hospital General Universitario Gregorio MaranonMadridSpain
Hospital Universitario Ramon Y CajalMadridSpain
Parc Tauli Hospital UniversitariSabadellSpain
Hospital Unviersitario Miguel ServetZaragozaSpain