5 completed, 2 terminated. 5 Phase 2, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 4, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF) HepaStem, Placebo - Acute on Chronic Liver Failure | Phase 2 | Terminated | Cellaion SA | 133 | 2020-01-21 | 2024-05-22 |
| Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients HepaStem - NASH - Nonalcoholic Steatohepatitis | Phase 1 / Phase 2 | Completed | Cellaion SA | 23 | 2019-04-09 | 2020-10-14 |
| HepaStem Long-Term Safety Registry Urea Cycle Disorder, Crigler-Najjar Syndrome | Terminated | Cellaion SA | 44 | 2018-04-04 | 2024-05-29 | |
| Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF HepaStem - Acute-On-Chronic Liver Failure | Phase 2 | Completed | Cellaion SA | 24 | 2016-12-01 | 2020-10-14 |
| Study to Evaluate the Efficacy of HepaStem in Urea Cycle Disorders Paediatric Patients (HEP002) HepaStem - Urea Cycle Disorders | Phase 2 | Completed | Cellaion SA | 5 | 2014-10-01 | 2020-10-19 |
| Long-term Safety Follow-up Study of Patients Having Received HepaStem (SAF001) Urea Cycle Disorders, Crigler Najjar Syndrome | Completed | Cellaion SA | 9 | 2013-03-01 | 2019-05-28 | |
| Safety Study of HepaStem for the Treatment of Urea Cycle Disorders (UCD) and Crigler-Najjar Syndrome (CN) HepaStem - Urea Cycle Disorders, Crigler Najjar Syndrome | Phase 1 / Phase 2 | Completed | Cellaion SA | 20 | 2012-03-01 | 2020-10-19 |
Urea Cycle Disorders, Inborn (4) · Acute-On-Chronic Liver Failure (3) · Crigler-Najjar Syndrome (3) · Non-alcoholic Fatty Liver Disease (1)
Belgium (7) · France (6) · Spain (4) · Bulgaria (3) · Poland (3) · Italy (2) · Austria (1) · Denmark (1) · Estonia (1) · Germany (1) · Israel (1) · Latvia (1) · Lithuania (1) · North Macedonia (1) · Slovakia (1)
Dries Dobbelaere, MD/Prof (1) · Giuliano Torre, MD (1) · Hanna Mandel, MD (1) · Stephanie Grunewald, MD (1)