Liver Failure
Conditions
Brief summary
HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.
Interventions
GENETICConventional plus BM-MSC treatment
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times).
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times)
DRUGConventional treatment
Received conventional treatment including: A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al); B.Hepatoprotective drugs(Ademetionine1,4-butanethiosulfonate for Injection, Reduced Glutathione for Injection,Polyene Phosphatidylcholine, et al); C.Plasma.
Sponsors
Third Affiliated Hospital, 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
* Aged 18-65 years * Liver failure * Negative pregnancy test (female patients in fertile age) * Written consent * HBsAg positive * TB≥171 μmol/L or ascend ≥17.1 μmol/L/per day, * INR≥1.5 or 20%\<PTA≤40% * 17≤MELD score≤30
Exclusion criteria
* Hepatocellular carcinoma or other malignancies * Severe problems in other vital organs(e.g.the heart,renal or lungs) * Pregnant or lactating women * Severe bacteria infection * Anticipated with difficulty of follow-up observation * Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on * Other candidates who are judged to be not applicable to this study by doctors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| survival rate | 72 weeks | The survival rate and time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The improvement of symptoms | 72 weeks after treatment | The improvement of clinical symptoms \[including appetite, debilitation, abdominal distension, edema of lower limbs, et al |
| The score for Model for End-Stage Liver Disease | 72 weeks after treatment | — |
| Marker of liver cancer | 72 weeks after treatment | The level of alpha-fetoprotein (AFP) |
| The degree of hepatic necrosis | 2 years after treatment | The levels of Prothrombin Activity (PA) and Prothrombin Time (PT) |
| The improvement of immune function | 72 weeks after treatment | cluster of differentiation 4 (CD4+)T/ cluster of differentiation 8 (CD8+)T,T helper cell 1 (Th1)/ T helper cell 1(Th2),natural killer cell(NK),natural killer T(NK T),interleukin-1β(IL-1β),interleukin-4(IL-4),interleukin-6(IL-6),interleukin-8(IL-8),interleukin-12(IL-12),interleukin-15(IL-15),interleukin-17A(IL-17A),Tumor necrosis factor-alpha (TNF-α),Interferon-gamma (IFN-γ) |
| complications | Between 0 to 8 hours after MSC transfusion | The occurrence of complications \[including body temperature, tetter and allergy\] |
| The incidence of hepatocellular carcinoma | 72 weeks after treatment | — |
| Liver function | 72 weeks after treatment | The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST),Cholinesterase (CHE) ,Total Bilirubin(TB),Direct Bilirubin(DB), Serum Albumin （ALB） |
Countries
China
Contacts
Primary ContactQihuan Xu, Doctor
Backup ContactQi Zhang, Doctor
Outcome results
None listed