Human Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure

Summary

This study is a randomized double-blind placebo-controlled multicenter clinical trial to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell (UC-MSC) transplantation for the treatment of acute-on-chronic liver failure (ACLF). UC-MSC therapy may improve the clinical outcomes of patients with ACLF. The trial would provide scientific evidence for UC-MSC transplantation as a potential treatment for ACLF.

Eligibility

Inclusion Criteria:

1. 18 years old ≤ age ≤ 70 years old, gender is not limited.
2. Meet the APASL definition of ACLF: acute liver injury in patients with previously diagnosed or undiagnosed chronic liver disease or cirrhosis, manifested as jaundice (total bilirubin levels of 5 mg/dl or more) and coagulopathy (INR of 1.5 or more, or prothrombin activity of less than 40%） complicated within 4 weeks by clinical ascites, encephalopathy, or both.
3. Willing to sign the informed consent form.

Exclusion Criteria:

1. Patients with acute kidney injury, upper gastrointestinal hemorrhage, hepatic encephalopathy above grade II (inclusive) or uncontrolled infection at baseline;
2. Before the onset of liver failure, the previous indicators of the patient included PLT\<50×10\^9/L or Child-Pugh score\>9;
3. Combined with liver cancer or other malignant tumors;
4. Patients with previous liver transplantation or planned liver transplantation within 3 months;
5. Severe organic disease of primary extrahepatic organs;
6. Those who have a history of venous thrombosis or pulmonary embolism are judged by the investigator to be ineligible to participate in this trial;
7. Pregnant, breastfeeding women or those who plan to have a baby in the near future;
8. Those who are highly allergic or have a history of severe allergies;
9. Those who have received immunosuppressant and immune enhancer treatment within 1 month;
10. Drug abuse in the past 5 years;
11. Alcohol withdrawal symptoms;
12. A history of severe mental disorders within 24 months before screening, including uncontrolled major depression or controlled or uncontrolled psychosis;
13. Those who have participated or are participating in other clinical trials within three months before screening, or have previously received stem cell therapy;
14. Other conditions that the investigator thinks that the patient is not suitable to participate in this study.

Conditions2

Interventions3

Related trials

• A Novel COMBinATorial Therapy With Albumin and Enoxaparin in Patients With Decompensated Cirrhosis at High-risk of Poor Outcome (COMBAT Trial). — European Foundation for Study of Chronic Liver Failure
• Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure — Institute of Liver and Biliary Sciences, India

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