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.
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.
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;
Parallel
standard medical treatment
Drugstandard medical treatment for ACLF
Placebo
Drug5% human serum albumin in 0.9% saline (at week0, week1 and week2)
hUC-MSC
DrughUC-MSC (1.5×10\^8 cells/time, Peripheral IV, at week0, week1 and week2)
hUC-MSC_Prolonged
DrughUC-MSC (1.5×10\^8 cells/time, Peripheral IV, at week4 and week5)
Transplantation free survival rate
Transplantation free survival rate of ACLF patients.
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability of UC-MSCs transplantation.
International Normalized Ratio (INR)
INR was introduced as a standardized reporting mechanism allowing comparisons across laboratories and patients. Consensus guidelines recommend that INR ≥ 1.5 can be used as a threshold, and current recommendations for targeting an INR of \< 1.5 were based on studies across all surgical disciplines.
Concentration of Total Bilirubin (TBIL, mg/dL)
Total bilirubin refers to the concentration of bilirubin in a patient's blood sample, which is automatically measured by the laboratories in accordance with standard operating procedures. APASL defines ACLF as "an acute hepatic insult manifesting as jaundice (Serum Bilirubin ≥ 5 mg/dL) and coagulopathy (international normalized ratio \[INR\] ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, that is associated with a high 28-day mortality."
Concentration of Serum Albumin (ALB, g/L)
Serum albumin refers to the concentration of albumin in a patient's serum, which is automatically measured by the laboratory in accordance with standard operating procedures. Serum albumin is an independent protective factor for 30-day prognosis in ACLF patients.
Concentration of Blood Urea Nitrogen (BUN, mmol/L)
Blood urea nitrogen refers to the concentration of urea nitrogen in a patient's blood sample. Blood urea nitrogen is a commonly used indicator of renal function in clinic.
Click on the lead sponsor to view all of their trials.
Beijing 302 Hospital
Lead sponsor
Shulan (Hang Zhou) Hospital
Collaborator
BeijingYouan Hospital
Collaborator
Shenzhen Third People's Hospital
Collaborator
Shen Zhen Wingor Biotechnology CO. LTD
Collaborator
