Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure
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|ClinicalTrials.gov Identifier: NCT01844063|
Recruitment Status : Recruiting
First Posted : May 1, 2013
Last Update Posted : July 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Liver Failure||Genetic: Conventional plus BM-MSC treatment Genetic: Conventional plus UC-MSC treatment Drug: Conventional treatment||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2019|
Experimental: Conventional treatment
Participants will receive conventional treatment and then be followed until the week 72 study visit.
Drug: Conventional 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.
Experimental: Conventional plus BM-MSC 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
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).
Experimental: Conventional plus UC-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)
- survival rate [ Time Frame: 72 weeks ]The survival rate and time
- Liver function [ Time Frame: 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）
- Marker of liver cancer [ Time Frame: 72 weeks after treatment ]The level of alpha-fetoprotein (AFP)
- The degree of hepatic necrosis [ Time Frame: 2 years after treatment ]The levels of Prothrombin Activity (PA) and Prothrombin Time (PT)
- The improvement of symptoms [ Time Frame: 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 [ Time Frame: 72 weeks after treatment ]
- The improvement of immune function [ Time Frame: 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 [ Time Frame: Between 0 to 8 hours after MSC transfusion ]The occurrence of complications [including body temperature, tetter and allergy]
- The incidence of hepatocellular carcinoma [ Time Frame: 72 weeks after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844063
|Contact: Qihuan Xu, Doctor||+86 20 firstname.lastname@example.org|
|Contact: Qi Zhang, Doctor||+86 20 email@example.com|
|Guangzhou, Guangdong, China, 510630|
|Principal Investigator: Qi Zhang, Doctor|
|Principal Investigator:||Qi Zhang, Doctor||Third Affiliated Hospital, Sun Yat-Sen University|