A pilot study evaluating the safety of intravenously administered human amnion epithelial cells for the treatment of hepatic fibrosis

Phase 1

Completed

• Conditions: cirrhosis; liver fibrosis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616000437460
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-06
• Study Completion: 2022-08-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Adult female or male patients, age 18 years to 70 years

Liver disease due to non-alcoholic fatty liver disease, alcohol related liver disease (must be abstinent for at least 3 months), hepatitis C virus infection (treated or not treated), hepatitis B virus infection (on nucleoside analogues with normal ALT and HBV DNA viral load) or inactive phase, HIV co-infection with HCV/HBV with virological suppression >12 months, cryptogenic cirrhosis, haemochromatosis (on maintenance venesection)

Cirrhosis, defined as one of: liver biopsy confirming cirrhosis, transient elastography (Fibroscan) with a liver stiffness measurement (LSM) >12.5 kPa, FIB 4 >3.25, or clinical and radiological features that in the opinion of the investigator are consistent with a diagnosis of cirrhosis. Compensated cirrhosis will be defined as a hepatic venous pressure gradient between 6 - 10 mmHg.

Exclusion Criteria

Patients will be excluded from the study if they have current or previous episodes of decompensated liver disease, including variceal haemorrhage, hepatic encephalopathy, ascites, are listed for liver transplantation, have primary biliary cholangitis, autoimmune hepatitis or other active autoimmune disease (IgG >2xULN), renal insufficiency (eGFR < 70mL/min/1.73m2), HIV infection (untreated or uncontrolled viraemia), HBV DNA >200 IU/mL, fulminant hepatitis (severe acute hepatitis withencephalopathy), primary sclerosing cholangitis, portal/hepatic vein thrombosis, significant comorbidity (chronic heart failure, COAD, pulmonary hypertension, diabetes or other in the investigator’s opinion), pregnancy, fibrotic liver disease other than cirrhosis (nodular regenerative hyperplasia), inability or unwillingness to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified