Clinical Trials Logo

Clinical Trial Summary

Acute-on-chronic liver failure (ACLF) refers to a liver failure syndrome in which some patients with chronic liver disease with relatively stable liver function suffer from acute liver decompensation and liver failure due to the effects of various acute injury factors,while acute liver failure (ALF) refers to 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. Liver transplantation is the only curative treatment for this type of end-stage liver disease, but the rapid disease progression and lack of donors limit its application. The potential of MSCs to repair or regenerate damaged tissue and suppress immune responses makes them promising in the treatment of liver diseases, especially in the field of liver transplantation. Many studies have shown that MSC-based therapies can reduce the symptoms of liver disease due to their paracrine effects. It has been confirmed in previous studies that infusion of allogeneic MSCs is safe and convenient for patients with ACLF and improve liver function and decrease the incidence of severe infections. Compared to the cells they derive from, mesenchymal stem cells-derived extracellular vesicles (MSC-EVs) are gradually gaining attention for their enhanced safety, as they do not replicate or cause microvascular embolism, and can be easily stored without losing their properties. It represents a novel and effective cell-free therapeutic agent as alternative to cell-based therapies for liver diseases, and liver failure was also concerned. This study was designed to evaluate the safety and efficacy of MSC-EVs in ACLF/ALF .


Clinical Trial Description

In the MSC-EV group (experimental group), onthe basis of standard medical treatment, 10 patients will receive a single injection of MSC-EV . In the non-MSC-EV group (control group), 10 patients will not receive MSC-EV therapy but standard medical treatment. The standard medical treatment iclude nutritional supplementation, administration of human serum albumin and fresh frozen plasma, anti-viral therapy (if hepatitis virus-related ACLF/ALF), liver protective treatment and other appropriate treatment for complications. The outcome of the experimental group will be compared with that of similar control patients who will not receive MSC-EV. Both of the two groups will receive standard medical treatment. Patients participated in the experimental cohort will be infused with a single dose of 10 E10 MSC-EV particles per 100ml, when they are inpatient. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05940610
Study type Interventional
Source Third Affiliated Hospital, Sun Yat-Sen University
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date September 1, 2023
Completion date October 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05985863 - Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure Phase 1/Phase 2
Not yet recruiting NCT04822922 - Safety of UC-MSC Transfusion for ACLF Patients Phase 2
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Completed NCT04983108 - Utility of Liver and Splenic Stiffness in Predicting Esophageal Varices in Patients With Acute on Chronic Liver Failure
Not yet recruiting NCT05036031 - Transplantation for EASL-CLIF and APASL ACLF Patients: a Retrospective Cohort Study
Recruiting NCT05019352 - Cytokine Adsorption in Acute-on-chronic Liver Failure N/A
Recruiting NCT05421351 - Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF
Completed NCT02321371 - Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy. N/A
Not yet recruiting NCT06069037 - SALT for Treatment of Patients With Early ACLF N/A
Completed NCT02965560 - Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure
Recruiting NCT03713489 - Platelet Transfusion in HBV-related acute-on Chronic Liver Failure N/A
Withdrawn NCT03629015 - Safety Study of Stemchymal® in Acute Liver Failure Phase 1
Recruiting NCT04621812 - Role of Fecal Microbiota in Predicting Graft Rejection and Sepsis Among Recipients of Living Donor Liver Transplant in First Year.
Recruiting NCT04157465 - Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients N/A
Suspended NCT03737448 - TRimetazidine for acUte on Chronic Liver Failure STudy Phase 1
Recruiting NCT06128421 - Individual Nutrition Support in HBV-ACLF Patients at Nutrition Risk N/A
Recruiting NCT05700708 - Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Refractory Ascites
Completed NCT04238416 - Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF Phase 1
Completed NCT03456518 - Pattern of Acute on Chronic Liver Failure in Patient With HCV Related Chronic Liver Disease
Recruiting NCT03987893 - PEG3350 in ACLF With Hepatic Encephalopathy Phase 4