HepaStem

DRUG7 trials

Sponsors

Cellaïon SA, Cellaion SA

Conditions

ACLF combines an acute deterioration of liver function in an individual with pre-existing chronic liver disease and extrahepatic organ failures characterized by high short-term mortality (30-40% at 28 days). The development of ACLF is associated with exacerbated systemic inflammation that may indeed cause organ failures.Acute on Chronic Liver FailureAcute-On-Chronic Liver FailureCirrhotic patients who are hospitalized for Acute on chronic liver failure (ACLF)Crigler Najjar SyndromeCrigler-Najjar (CN) and Fibroinflammatory liver diseases.NASH - Nonalcoholic SteatohepatitisThis study will include all patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HALPC during a previous interventional clinical study conducted by Promethera Biosciences or Promethera Therapeutics including patients suffering from urea cycle disorders (UCD)

Phase 1

Safety Study of HepaStem for the Treatment of Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN)

CompletedNCT01765283

Cellaion SACrigler Najjar Syndrome, Urea Cycle Disorders

Start: 2012-03-31End: 2015-04-30Updated: 2020-10-19

Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients

CompletedNCT03963921

Cellaion SANASH - Nonalcoholic Steatohepatitis

Start: 2019-04-09End: 2020-08-31Updated: 2020-10-14

Phase 2

Study to Evaluate the Efficacy of HepaStem in Urea Cycle Disorders Paediatric Patients (HEP002)

CompletedNCT02489292

Cellaion SAUrea Cycle Disorders

Start: 2014-10-31End: 2017-03-31Updated: 2020-10-19

Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF

CompletedNCT02946554

Cellaion SAAcute-On-Chronic Liver Failure

Start: 2016-12-31End: 2020-07-31Updated: 2020-10-14

Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)

TerminatedNCT04229901

Cellaion SAAcute on Chronic Liver Failure

Start: 2020-01-21End: 2024-05-10Updated: 2024-05-22

Randomized, placebo-controlled, double blind, multi-centre Phase IIb stuDy to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) – DHELIVER

CompletedCTIS2022-500252-28-00

Cellaïon SAACLF combines an acute deterioration of liver function in an individual with pre-existing chronic liver disease and extrahepatic organ failures characterized by high short-term mortality (30-40% at 28 days). The development of ACLF is associated with exacerbated systemic inflammation that may indeed cause organ failures., Cirrhotic patients who are hospitalized for Acute on chronic liver failure (ACLF)

Start: 2019-12-17End: 2024-05-10Target: 132Updated: 2023-10-13

HepaStem Long-Term Safety Registry – Registry for Patients who have been administered HepaStem

CompletedCTIS2022-500251-22-00

Cellaïon SACrigler-Najjar (CN) and Fibroinflammatory liver diseases., This study will include all patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HALPC during a previous interventional clinical study conducted by Promethera Biosciences or Promethera Therapeutics including patients suffering from urea cycle disorders (UCD)

Start: 2018-04-12End: 2024-05-23Target: 67Updated: 2024-05-21

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