Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-20 @ 4:45 PM
Study NCT ID:
NCT03343756
Status:
TERMINATED
Last Update Posted:
2024-05-29
First Post:
2017-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HepaStem Long-Term Safety Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056806', 'term': 'Urea Cycle Disorders, Inborn'}, {'id': 'D003414', 'term': 'Crigler-Najjar Syndrome'}, {'id': 'D065290', 'term': 'Acute-On-Chronic Liver Failure'}], 'ancestors': [{'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006933', 'term': 'Hyperbilirubinemia, Hereditary'}, {'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sponsor decision related to product development prioritisation.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-27', 'studyFirstSubmitDate': '2017-11-10', 'studyFirstSubmitQcDate': '2017-11-10', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Adverse Events of Specific Interest (AESI)', 'timeFrame': '60 months', 'description': 'Adverse Events of Specific Interest (AESI):\n\n* Event with fatal outcome (Death)\n* Orthotopic Liver Transplantation (OLT) and Outcome.\n* Development of Malignancy or unwanted tissue formation in different organs (tumor malignant or not).\n* Disease linked to transmission of adventitious agents or reactivation of latent pathogens.\n* Any AE which in the opinion of the Investigator has a plausible causal relationship to HepaStem.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urea Cycle Disorder', 'Crigler-Najjar Syndrome', 'Acute on Chronic Liver Failure']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who received HepaStem in the interventional studies conducted by Promethera will be proposed to participate in this PROLONGSTEM study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients having received at least one infusion of HepaStem during a previous interventional clinical study conducted by Promethera.\n\nExclusion Criteria:\n\n* Patients who received an OLT and completed 6-month FU documentation prior to the start of the PROLONGSTEM study.\n* Patients who have received mature liver cells or stem cells other than HepaStem prior to the start of the PROLONGSTEM study.'}, 'identificationModule': {'nctId': 'NCT03343756', 'acronym': 'PROLONGSTEM', 'briefTitle': 'HepaStem Long-Term Safety Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cellaion SA'}, 'officialTitle': 'HepaStem Long-Term Safety Registry - Registry for Patients Who Have Been Administered HepaStem', 'orgStudyIdInfo': {'id': 'PROLONGSTEM'}}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Anderlecht', 'country': 'Belgium', 'facility': 'Hopital Erasme', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}, {'zip': '2650', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'UCL', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHC MontLegia', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Woluwe-Saint-Lambert', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.84389, 'lon': 4.42912}}, {'zip': '5803', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '7013', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'UMHAT Medica Ruse', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Military Medical Academy', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '80080', 'city': 'Amiens', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': "Centre Hospitalier Universitaire D'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33608', 'city': 'Bordeaux', 'country': 'France', 'facility': 'University Hospital Of Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69317', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils De Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hopitaux De Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire De Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Assistance Publique Hopitaux De Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Les Hopitaux Universitaires De Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94804', 'city': 'Villejuif', 'country': 'France', 'facility': 'Hopital Paul Brousse', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '41-400', 'city': 'Mysłowice', 'country': 'Poland', 'facility': 'Id Clinic', 'geoPoint': {'lat': 50.20745, 'lon': 19.16668}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital De La Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28049', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramon Y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '08208', 'city': 'Sabadell', 'country': 'Spain', 'facility': 'Parc Tauli Hospital Universitari', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Unviersitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cellaion SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}