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Recruiting Phase 1, Phase 2 NCT05985863

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

Trial Parameters

Condition Acute-On-Chronic Liver Failure
Sponsor Beijing 302 Hospital
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2023-09-30
Completion 2026-12-30
Interventions
standard medical treatmentPlacebohUC-MSC

Brief 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 Criteria

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 extrahe

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