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Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)

Primary Purpose

Liver Failure

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Group 1
Group 2
Group 3
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Failure focused on measuring ABMLF, Allogenic Bone marrow Mesenchymal Stem Cells, Liver Failure, Transplantation

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Liver failure caused by HBV
  • Model for End-Stage Liver Disease (MELD) < 30

Exclusion Criteria:

  • Liver Failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on.
  • History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment.
  • Severe problems in other vital organs (e.g.the heart,renal or lungs).
  • Tumor on ultrasonography, CT or MRI examination.
  • Pregnant or lactating women.
  • HIV infection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Group A

    Arm Description

    Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

    Outcomes

    Primary Outcome Measures

    Liver Function
    The levels of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST),total bilirubin (TB),prothrombin time (PT), prothrombin activity(PTA),INR,albumin (ALB),globulin(GLB), prealbumin(PA),creatinine(Cr), Urea nitrogen(BUN),number of leucocyte,erythrocyte and platelet, cytokines,liver histological
    Immune state
    cytokine

    Secondary Outcome Measures

    Full Information

    First Posted
    March 24, 2011
    Last Updated
    April 8, 2011
    Sponsor
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01322906
    Brief Title
    Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)
    Official Title
    Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by HBV
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    November 2011 (Anticipated)
    Study Completion Date
    July 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sun Yat-sen University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure Caused by hepatitis B virus (HBV)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Failure
    Keywords
    ABMLF, Allogenic Bone marrow Mesenchymal Stem Cells, Liver Failure, Transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Other
    Arm Description
    Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
    Intervention Type
    Other
    Intervention Name(s)
    Group 1
    Intervention Description
    Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(2×105/Kg, once a week, 4 times).
    Intervention Type
    Other
    Intervention Name(s)
    Group 2
    Intervention Description
    Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(1×106/Kg, once a week, 4 times).
    Intervention Type
    Other
    Intervention Name(s)
    Group 3
    Intervention Description
    Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(5×106/Kg, once a week, 4 times).
    Primary Outcome Measure Information:
    Title
    Liver Function
    Description
    The levels of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST),total bilirubin (TB),prothrombin time (PT), prothrombin activity(PTA),INR,albumin (ALB),globulin(GLB), prealbumin(PA),creatinine(Cr), Urea nitrogen(BUN),number of leucocyte,erythrocyte and platelet, cytokines,liver histological
    Time Frame
    12months
    Title
    Immune state
    Description
    cytokine
    Time Frame
    12months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Liver failure caused by HBV Model for End-Stage Liver Disease (MELD) < 30 Exclusion Criteria: Liver Failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on. History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment. Severe problems in other vital organs (e.g.the heart,renal or lungs). Tumor on ultrasonography, CT or MRI examination. Pregnant or lactating women. HIV infection.

    12. IPD Sharing Statement

    Learn more about this trial

    Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)

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