The Safety and Efficacy of MSC-EVs in Acute/Acute-on-Chronic Liver Failure
Acute-On-Chronic Liver Failure, Acute Liver Failure
About this trial
This is an interventional treatment trial for Acute-On-Chronic Liver Failure focused on measuring MSC-EVs, Acute-on-chronic liver failure, Acute liver failure, Liver transplantation
Eligibility Criteria
Inclusion Criteria: aged 18-65 years old; 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; Acute liver failure-a potentially reversible disorder that was the result of severe liver injury, with an onset of encephalopathy within 8 weeks of symptom appearance and in the absence of pre-existing liver disease. Total bilirubin (TBil) ≥ 171umolL or daily increase ≥17.1umol/L; Prothrombin activity (PTA) between 20% and 40% (or INR between 1.5 and 2.6); No hepatic encephalopathy, or encephalopathy below grade II (including grade II); Exclusion Criteria: Patients with primary or metastatic liver cancer Severe active bleeding or diffuse intravascular coagulation Patients who are allergic to blood products or drugs used in treatment, such as plasma, heparin and protamine; MELD score >30 Other serious disease including heart disease, lung disease, blood disease, autoimmune disease, diabetes, active uncontrolled infection,etc.
Sites / Locations
- Third Affiliated Hospital, Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
MSC-EV group
Non-MSC-EV group
On the basis of standard medical treatment, an additional injection of MSC-EVs will be received by participants once a week for 4 weeks while hospitalized.
In the non-MSC-EV group, patients will receive standard medical treatment and 100ml saline as a control.