A Phase 1/2 interventional study of Conventional plus BM-MSC treatment and Conventional plus UC-MSC treatment in Liver Failure, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-07-08.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Phase 1/2, Interventional, and Treatment
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.
445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.
This study's planned enrollment of 210 is above the median of 43 across 276 interventional studies indexed under Liver Failure.
Browse Liver Failure studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 130 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive conventional treatment and then be followed until the week 72 study visit.
Drug: Conventional treatment
Participants will receive conventional treatment plus a dose of BM-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.
Genetic: Conventional plus BM-MSC treatment
Participants will receive conventional treatment plus a dose of UC-MSC(each subgroups with a different dose ) and then be followed until the week 72 study visit.
Genetic: Conventional plus UC-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)
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.
Also known as: Antiviral drugs, Hepatoprotective drugs, Plasma
survival 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
This study is status unknown, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Third Affiliated Hospital, Sun Yat-Sen University