HepaStem Long-Term Safety Registry - Registry for Patients Who Have Been Administered HepaStem
| Registry | NCT03343756, acronym PROLONGSTEM |
|---|---|
| Status | Terminated - Sponsor decision related to product development prioritisation. |
| Study type | Observational |
| Enrollment | 44 (Actual) |
| Sponsor | Cellaion SA (Industry) |
| Conditions | Urea Cycle Disorder, Crigler-Najjar Syndrome, Acute on Chronic Liver Failure |
| Dates | start 2018-04-04, primary completion 2024-05-23, completion 2024-05-23, first posted 2017-11-17, last updated 2024-05-29 |
| Locations | 29 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
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
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Hopital Erasme | Anderlecht | Belgium | |
| Antwerp University Hospital | Antwerp | Belgium | |
| Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann | Brussels | Belgium | |
| UCL | Brussels | Belgium | |
| Universitair Ziekenhuis Gent | Ghent | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| CHC MontLegia | Liège | Belgium | |
| Cliniques Universitaires Saint-Luc | Woluwe-Saint-Lambert | Belgium | |
| University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD | Pleven | Bulgaria | |
| UMHAT Medica Ruse | Rousse | Bulgaria | |
| Military Medical Academy | Sofia | Bulgaria | |
| 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 | France | |
| Id Clinic | Mysłowice | Poland | |
| 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 | Spain |