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

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ClinicalTrials.gov Identifier: NCT01322906
Recruitment Status : Unknown
Verified October 2010 by Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : March 25, 2011
Last Update Posted : April 11, 2011
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Liver Failure Other: Group 1 Other: Group 2 Other: Group 3 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by HBV
Study Start Date : March 2011
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : July 2012
Arms and Interventions

Arm Intervention/treatment
Group A
Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Other: Group 1
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).
Other: Group 2
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).
Other: Group 3
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).


Outcome Measures

Primary Outcome Measures :
  1. Liver Function [ Time Frame: 12months ]
    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

  2. Immune state [ Time Frame: 12months ]
    cytokine


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
More Information

Responsible Party: Lin Bingliang, Third Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01322906     History of Changes
Other Study ID Numbers: ABMS-LF
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: October 2010

Keywords provided by Sun Yat-sen University:
ABMLF
Allogenic Bone marrow Mesenchymal Stem Cells
Liver Failure
Transplantation

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases