Liver Failure
Conditions
Interventions
Experimental Group:Administration of PT-MSC-derived exosomes at a dose of 1–2 × 10^11 particles per dose
Sponsors
Second Department of Hepatobiliary Medicine Zhujiang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years. 2. Patients in the early or intermediate stages of liver failure due to various etiologies. 3. Total bilirubin (TBil) >=171 µmol/L or with a daily increase >=17.1 µmol/L. 4. Prothrombin activity (PTA) of 20%–40% (or International Normalized Ratio [INR] of 1.5–2.6). 5. Absence of hepatic encephalopathy or presence of hepatic encephalopathy up to grade II (inclusive). 6. Elevated inflammatory markers (e.g., IL-6, TNF-a, CRP). 7. Subjects capable of effective communication with investigators and adherence to study protocols. 8. Subjects must provide informed consent prior to the trial and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of severe active bleeding or disseminated intravascular coagulation (DIC). 2. Hypersensitivity to blood products or medications used during treatment (e.g., plasma, heparin, protamine). 3. Patients with circulatory failure. 4. MELD (Model for End-Stage Liver Disease) score >30. 5. Severe cardiac, pulmonary, hematological, autoimmune diseases, or uncontrolled diabetes mellitus.Subjects deemed unsuitable for participation due to other reasons or investigator’s discretion. 6. Subjects deemed unsuitable for participation due to other reasons or investigator’s discretion. 7. Pregnant or lactating women; history of organ transplantation. 8. Patients scheduled to undergo hormonal therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rates at 4, 8, and 12 weeks post-treatment;MELD Score;Adverse Event (AE) Incidence Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver disease-related indicators (PTA, ALT, AST, lactate, blood ammonia, alpha-fetoprotein [AFP], albumin, etc.);IL-6, TNF-a, CRP;Coagulation Function(Plasma Prothrombin Time (PT) International Normalized Ratio (INR) Prothrombin Activity (PT%) Activated Partial Thromboplastin Time (APTT) Fibrinogen (FIB) Thrombin Time (TT) D-Dimer); | — |
Countries
China
Contacts
Public ContactKebo Zhong
Second Department of Hepatobiliary Medicine Zhujiang Hospital, Southern Medical University
Outcome results
None listed