RecruitingPhase 1Phase 2NCT05985863

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

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

Sponsor

Beijing 302 Hospital

Enrollment

150 participants

Start Date

Sep 30, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria3

18 years old ≤ age ≤ 70 years old, gender is not limited.
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.
Willing to sign the informed consent form.

Exclusion Criteria14

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