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Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Sun Yat-sen University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01221454
First received: October 12, 2010
Last updated: October 15, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Liver Failure
 Procedure: Allogenic bone marrow stem cells transplantation
Drug: Conserved therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Liver Function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Immune function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221454

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

Additional Information:
The Third Affiliated Hospital of Sun Yat-sen University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Lin Bingliang, Third Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01221454     History of Changes
Other Study ID Numbers: SYS-LF
Study First Received: October 12, 2010
Last Updated: October 15, 2010
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Liver Failure
Hepatitis B, Chronic
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Hepatitis B
 Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic
Hepatitis

ClinicalTrials.gov processed this record on May 22, 2013