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Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

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ClinicalTrials.gov Identifier: NCT01221454
Recruitment Status : Unknown
Verified October 2010 by Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : October 15, 2010
Last Update Posted : October 18, 2010
Sponsor:
Information provided by:
Sun Yat-sen University

Brief Summary:
The purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver failure caused by hepatitis B infection. The evaluation of the efficacy includes the level of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores, MELD scores and clinical symptoms were also observed simultaneously.

Condition or disease Intervention/treatment Phase
Liver Failure Procedure: Allogenic bone marrow stem cells transplantation Drug: Conserved therapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Failure Resulting From Chronic Hepatitis B
Study Start Date : October 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Arm Intervention/treatment
Active Comparator: Group A(conserved therapy )
Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Drug: Conserved therapy
Oral or intravenous administration
Experimental: Group B (BMSC Transplantion)
Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as bone marrow stem cells transplantation
Procedure: Allogenic bone marrow stem cells transplantation
30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy



Primary Outcome Measures :
  1. Liver Function [ Time Frame: 12 months ]
    The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), number of leucocyte,erythrocyte and platelet, cytokines, T lymphocyte and B lymphocyte,liver histological


Secondary Outcome Measures :
  1. Immune function [ Time Frame: 12 months ]


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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:

  • Aged 16~65 years.
  • Serum HBsAg positive for over six months.
  • Meet the diagnostic criteria of liver failure:

Exclusion Criteria:

  • History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
  • Prothrombin time is over 30s.
  • Cirrhosis caused by other reasons except HBV infection.
  • Severe problems in other vital organs(e.g.the heart,renal or lungs).
  • Liver tumor on ultrasonography, CT or MRI examination.
  • Pregnant or lactating women.
  • Imaging evidences of vascular thromboses.

Information from the National Library of Medicine

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): NCT01221454


Locations
China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Sun Yat-sen University

Additional Information:
Responsible Party: Lin Bingliang, Third Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01221454     History of Changes
Other Study ID Numbers: SYS-LF
First Posted: October 15, 2010    Key Record Dates
Last Update Posted: October 18, 2010
Last Verified: October 2010

Keywords provided by Sun Yat-sen University:
ABMSC
Allogenic bone marrow mesenchymal stem cells
Liver Failure
Transplantation

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