Liver Failure
Conditions
Brief summary
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24 weeks survival rate of ACLF patients. In this study, we intend to assess the safety and efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.
Interventions
DRUGumbilical cord blood mesenchymal stem cells
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with ACLF-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio≥ 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; 2. Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months; 3. End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.
Exclusion criteria
1. Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection ); 2. Concomitant autoimmune disease; 3. Superinfection with other hepatitis viruses; 4. Important organ dysfunctions not due to liver disease or malignancies; 5. Pregnancy and lactation; 6. Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging; 7. Bioartificial liver support therapy; 8. Previous liver transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions. | 52 weeks |
| The survival time of patients after UC-MSC infusions. | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The influence on levels of TBil (umol/L) after UC-MSC infusions | 1,2,3,4,8,12,24,36,52weeks |
| The influence on levels of INR after UC-MSC infusions | 1,2,3,4,8,12,24,36,52weeks |
| The influence on levels of MELD score, SOFA score and CTP score after UC-MSC infusions | 1,2,3,4,8,12,24,36,52weeks |
| The incidence of fatal complications after UC-MSC infusions. | 52 weeks |
| Comparison of levels of NKG2A among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of NKG2D among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| The influence on levels of ALT (U/L) and AST (U/L) after UC-MSC infusions | 1,2,3,4,8,12,24,36,52weeks |
| Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of perforin among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of FasL among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of gramzymeB among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| Comparison of levels of NKP46 among the groups after UC-MSC infusions | 2,4,8,12,24,36,52 weeks |
| The influence on levels of ALB(g/L) after UC-MSC infusions | 1,2,3,4,8,12,24,36,52weeks |
Outcome results
None listed