Набор скоро начнётся NCT06825572

MSC-EVs in Acute/ Acute-on-Chronic Liver Failure After Liver Transplantation

Фаза I С лечением Liver Failure Mesenchymal Stem Cell Extracellular Vesicles

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: MSC-EVs.
Кому может быть актуально: Состояния в реестре: Liver Failure, Mesenchymal Stem Cell, Extracellular Vesicles. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Mesenchymal Stem Cells-Derived Extracellular Vesicles (MSC-EV) in Acute/Acute-on-Chronic Liver Failure After Liver Transplantationa：a Prospective, Randomized, Controlled Clinical Study

Обзор

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.

Подробное описание

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.

Вмешательства

Биопрепарат 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

Первичные конечные точки

Number of participants with MSC-EV infusion-related toxicity as assessed by CTCAE v4.0. [Срок оценки: 24 hours after injection]
Aspartate aminotransferase (AST) [Срок оценки: 6 months after transplantation]
Alanine aminotransferase (ALT) [Срок оценки: 6 months after transplantation]
Bilirubin level [Срок оценки: 6 months after transplantation]
International normalized ratio (INR) [Срок оценки: 6 months after transplantation]
carbohydrate Compound antigen (GGT) level [Срок оценки: 6 months after transplantation]
Adverse events [Срок оценки: 6 months after transplantation]

Вторичные конечные точки (3)

Number of survived patients at 1 year after liver transplantation, according to the follow-up results. [Срок оценки: 12 months]
Number of survived grafts at 1 year after liver transplantation, according to the follow-up results. [Срок оценки: 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. [Срок оценки: 6 months after transplantation]

Критерии участия

Критерии включения

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;