MSC-EVs in Acute/ Acute-on-Chronic Liver Failure After Liver Transplantation

Launched by THIRD AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Feb 9, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a new treatment called MSC-EVs (mesenchymal stem cell-derived extracellular vesicles) for patients experiencing acute-on-chronic liver failure after liver transplantation. Acute-on-chronic liver failure occurs when someone with long-term liver problems suddenly becomes much worse due to a new injury. The goal of this study is to see if MSC-EVs can be safely given to these patients and if they can help improve their condition. MSC-EVs are interesting because they come from stem cells and may help repair liver damage without the risks that come with using live cells.

To participate in this study, patients should be between 18 and 70 years old and must have been diagnosed with acute-on-chronic liver failure that requires a liver transplant. This includes symptoms like jaundice (yellowing of the skin) and problems with blood clotting. Patients who have a history of cancer, active infections, or certain viral infections like HIV or HCV are not eligible. Participants will be informed about the purpose of the trial and what to expect, and they must give their consent to take part. The study is not yet recruiting participants, but it represents an exciting opportunity to explore new treatments for serious liver conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • aged 18-70 years;
• • Acute on chronic liver failure-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin \[TBil\] ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio \[INR\] ≥ 1.5 or prothrombin activity \< 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease; Requiring liver transplantation due to acute on chronic liver failure;
• • Obtain the patients' consent after informing patients of the purpose and method of the clinical trial;
• Exclusion Criteria:
• • Past history of malignant disease
• • Active uncontrolled infection;
• • Combined transplantation
• • EBV-negative;
• • HIV or HCV positive;
• • Retransplantation;