A Phase 1 interventional study of MSC-EV in Liver Failure, Acute on Chronic, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Withdrawn at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Phase 1, Interventional, and Treatment
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.
In the MSC-EV group (experimental group), 15 patients will receive a single injection of MSC-EV after their first liver transplantation. In the non-MSC-EV group (control group), 15 patients will not receive MSC-EV therapy after their first liver transplantation.
The outcome of the experimental group will be compared with that of similar control patients undergoing liver transplantation but who will not receive MSC-EV. Both of the two groups will receive standard immunosuppressive therapy( a regimen based on tacrolimus (TAC), mycophenolate mofetyl (MMF) and steroids). Patients participated in the experimental cohort will be infused with a single dose of 10 E10 MSC-EV particles per 100ml, at an appropriate time during the first 1-5 days after transplantation.
445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.
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Exclusion Criteria:
After liver transplantation, on the basis of postoperative standard treatment (anti-infection treatment, immunosuppressive treatment, nutritional support treatment, etc.), an additional injection of MSC-EV will be received between the 1st and 5th days after transplantation
Biological: MSC-EV
After liver transplantation, patients will receive postoperative standard treatment (anti-infection treatment, immunosuppressive treatment, nutritional support treatment, etc.)
10 E10 MSC-EV particles per 100ml for a single dose. No prior HLA matching between MSC donors and recipients or liver donors
Number of participants with MSC-EV infusion-related toxicity as assessed by CTCAE v4.0.
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 .
Time frame: 24 hours after injection
Aspartate aminotransferase (AST)
Collect clinical results reflecting liver function
Time frame: 6 months after transplantation
Alanine aminotransferase (ALT)
Collect clinical results reflecting liver function
Time frame: 6 months after transplantation
Bilirubin level
Collect clinical results reflecting liver function
Time frame: 6 months after transplantation
International normalized ratio (INR)
Collect clinical results reflecting liver function
Time frame: 6 months after transplantation
carbohydrate Compound antigen (GGT) level
Collect clinical results reflecting liver function
Time frame: 6 months after transplantation
Adverse events
Any adverse events which may related to MSC-EV infusion
Time frame: 6 months
Number of survived patients at 1 year after liver transplantation, according to the follow-up results.
Patients who are surviving, as assessed by outpatient or telephone follow-up, at 1 year after liver transplantation
Time frame: 12 months
Number of survived grafts at 1 year after liver transplantation, according to the follow-up results.
Surviving patients with primary and functional grafts, as assessed by outpatient or telephone follow-up, at 1 year after liver transplantation.
Time frame: 12 months
Recipient's immune function, as assessed by analysis of immune cell subsets from biopsy or blood samples ,at months 1-6 after liver transplantation.
A series of immune cell subsets will be analyzed, including T cells (CD3+), CD4+ T cells (CD3+ CD4+ lymphocytes), CD8+ T cells (CD3+ CD8+ lymphocytes), naïve CD4+ T cells (CD4+ CD45RAhigh lymphocytes), memory CD4+ T cells (CD4+ CD45RO+ lymphocytes), natural killer (NK) cells (CD3- CD56+ lymphocytes), as well as B cells (CD19+ lymphocytes)
Time frame: 6 months
This study is withdrawn, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Third Affiliated Hospital, Sun Yat-Sen University