MSC-EVs: 10 E10 MSC-EV particles per 100ml for a single dose. No prior HLA matching between MSC donors and recipients or liver donors
Study summary
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. Acute-on-chronic liver failure 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. Liver transplantation is the only curative treatment for this type of end-stage liver disease. 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. Therefore, compared to the cells they derive from, mesenchymal stem cells-derived extracellular vesicles (MSC-EV) 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 tolerability of MSC-EV in acute-on-chronic liver failure after liver transplantation.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
Number of participants with MSC-EV infusion-related toxicity as assessed by CTCAE v4.0. — 24 hours after injection Incidence, timing and severity of any clinical complication related to MSC-EV infusion, such as tympanic body temperature, heart rate, mean arterial blood pressure and allergy, as assessed by CTCAE v4.0 .
Aspartate aminotransferase (AST) — 6 months after transplantation Collect clinical results reflecting liver function
Alanine aminotransferase (ALT) — 6 months after transplantation Collect clinical results reflecting liver function
Bilirubin level — 6 months after transplantation Collect clinical results reflecting liver function
International normalized ratio (INR) — 6 months after transplantation Collect clinical results reflecting liver function
carbohydrate Compound antigen (GGT) level — 6 months after transplantation Collect clinical results reflecting liver function
Adverse events — 6 months after transplantation Any adverse events which may related to MSC-EV infusion
Trial sites (1)
Facility
City
Region
Status
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou
Guangdong
More Third Affiliated Hospital, Sun Yat-Sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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