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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
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)
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.
Qi Zhang
Guangzhou, Guangdong, China
RECRUITINGsurvival rate
The survival rate and time
Time frame: 72 weeks
Liver function
The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST),Cholinesterase (CHE) ,Total Bilirubin(TB),Direct Bilirubin(DB), Serum Albumin （ALB）
Time frame: 72 weeks after treatment
Marker of liver cancer
The level of alpha-fetoprotein (AFP)
Time frame: 72 weeks after treatment
The degree of hepatic necrosis
The levels of Prothrombin Activity (PA) and Prothrombin Time (PT)
Time frame: 2 years after treatment
The improvement of symptoms
The improvement of clinical symptoms \[including appetite, debilitation, abdominal distension, edema of lower limbs, et al
Time frame: 72 weeks after treatment
The score for Model for End-Stage Liver Disease
Time frame: 72 weeks after treatment
The improvement of immune function
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)
Time frame: 72 weeks after treatment
complications
The occurrence of complications \[including body temperature, tetter and allergy\]
Time frame: Between 0 to 8 hours after MSC transfusion
The incidence of hepatocellular carcinoma
Time frame: 72 weeks after treatment
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