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

Launched by CELLAION SA · Jan 11, 2020

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Are adults aged between 18 and 75 years old.
• • 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.
• Main Exclusion Criteria:
• • 1. Have a MELD-Na score \> 35.
• • 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%.