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Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01844063
Recruitment Status : Unknown
Verified July 2013 by Qi Zhang, MD, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : May 1, 2013
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Qi Zhang, MD, Third Affiliated Hospital, Sun Yat-Sen University

Tracking Information
First Submitted Date  ICMJE April 20, 2013
First Posted Date  ICMJE May 1, 2013
Last Update Posted Date July 8, 2013
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2013)
survival rate [ Time Frame: 72 weeks ]
The survival rate and time
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure
Official Title  ICMJE Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Failure
Intervention  ICMJE
  • 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).
  • 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)
  • 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.

    Other Names:
    • Antiviral drugs
    • Hepatoprotective drugs
    • Plasma
Study Arms  ICMJE
  • Experimental: Conventional treatment
    Participants will receive conventional treatment and then be followed until the week 72 study visit.
    Intervention: Drug: Conventional treatment
  • 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.
    Intervention: Genetic: Conventional plus BM-MSC treatment
  • 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.
    Intervention: Genetic: Conventional plus UC-MSC treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 27, 2013)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01844063
Other Study ID Numbers  ICMJE The Third Affiliated Hospital
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qi Zhang, MD, Third Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Third Affiliated Hospital, Sun Yat-Sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qi Zhang, Doctor Third Affiliated Hospital, Sun Yat-Sen University
PRS Account Third Affiliated Hospital, Sun Yat-Sen University
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP