Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)
NCT ID: NCT04229901
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
133 participants
INTERVENTIONAL
2020-01-21
2024-05-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF
NCT02946554
Efficacy & Safety of ALF-5755 in Patients With Nonacetaminophen Severe Acute Hepatitis & Early Stage Acute Liver Failure
NCT01318525
To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF).
NCT03162419
Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure
NCT00225901
Umbilical Cord-derived Mesenchymal Stem Cell Infusion for Treating ACLF
NCT06884904
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HepaStem
Patients in the HepaStem arm will receive 2 infusions of HepaStem (i.v) at 1.0 million of cells/kg of total body weight (7 day interval)
HepaStem
HepaStem will be administered as an intravenous (IV) infusion
Placebo
Patients in the placebo arm will receive 2 infusions of placebo (i.v) (7 day interval)
Placebo
Placebo will be administered as an intravenous (IV) infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HepaStem
HepaStem will be administered as an intravenous (IV) infusion
Placebo
Placebo will be administered as an intravenous (IV) infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Have an initial diagnosis of ACLF at the investigational site.
3. Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition.
4. Have a total bilirubin ≥ 5 mg/dL.
5. Are able to read, understand and give written informed consent.
Exclusion Criteria
2. Have underlying cirrhosis due to biliary disease.
3. Have underlying cirrhosis due to autoimmune hepatitis.
4. Have active bleeding at a non-compressible site or at a compressible site that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
5. Have received treatment for bleeding complications during the current hospitalization and has a persistent high risk for re-bleeding that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
6. Have a complete portal vein thrombosis.
7. Have coagulation disturbances defined as:
* fibrinogen \< 80 mg/dL
* platelets \< 50 x 10³/mm³
8. Are requiring chronic dialysis therapy.
9. Have had a cerebrovascular, myocardial, limb arterial thrombotic event, or history for both thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the Screening and not considered stabilized by the investigator.
10. Have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (EFR) ≤ 40%.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cellaion SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University Of Vienna
Vienna, , Austria
UZ Antwerpen
Antwerp, , Belgium
CHU Brugmann
Brussels, , Belgium
CHU Erasme
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHC MontLégia
Liège, , Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, , Belgium
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski"
Pleven, , Bulgaria
UMHAT Medica
Rousse, , Bulgaria
Military Medical Academy
Sofia, , Bulgaria
UMHAT Sveta Anna
Sofia, , Bulgaria
UMHAT Tzarita Joanna
Sofia, , Bulgaria
Aarhus University Hospital
Aarhus, , Denmark
North Estonia Regional Hospital
Tallinn, , Estonia
Lääne-Tallinna Keskhaigla AS
Tallinn, , Estonia
CHU Angers
Angers, , France
Hopital Beaujon
Clichy, , France
Assistance Publique Hopitaux De Paris
Créteil, , France
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, , France
Hospices Civils De Lyon
Lyon, , France
Assistance Publique Hopitaux De Marseille
Marseille, , France
CHU Montpellier
Montpellier, , France
Assistance Publique-Hopitaux de Paris - Hopitaux Universitaires Pitie-Salpetriere
Paris, , France
Les Hopitaux Universitaires De Strasbourg
Strasbourg, , France
CHU De Toulouse
Toulouse, , France
Hospital Paul Brousse
Villejuif, , France
Medizinische Hochschule Hannover
Hanover, , Germany
University Hospital Of Leipzig
Leipzig, , Germany
University Hospital Of Ulm AöR
Ulm, , Germany
Azienda Ospedaliera Ospedale Niguarda CA' Granda
Milan, , Italy
Azienda Ospedaliera Universitaria Policlinico
Palermo, , Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, , Italy
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Lietuvos Sveikatos Mokslų Universiteto Ligoninė Kauno Klinikos
Kaunas, , Lithuania
PHI General City Hospital "8mi Septemvri"
Skopje, , North Macedonia
PHI University Clinic of Gastroenterohepatology
Skopje, , North Macedonia
Id Clinic
Mysłowice, , Poland
Kliniczny Szpital Wojewódzki Nr 2 Im. Św. Jadwigi Królowej W Rzeszowie
Rzeszów, , Poland
F.D. Roosevelt University General Hospital Of Banská Bystrica
Banská Bystrica, , Slovakia
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
University Hospital Ramón Y Cajal
Madrid, , Spain
Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda, , Spain
Sabadell Hospital
Sabadell, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Unviersitario Miguel Servet
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HEP102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.