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

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:
NCT01322906
First received: March 24, 2011
Last updated: April 8, 2011
Last verified: October 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Liver Failure
 Other: Group 1
Other: Group 2
Other: Group 3
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by HBV

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: 12months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12months ] [ Designated as safety issue: No ]
    cytokine


Estimated Enrollment: 120
Study Start Date: March 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Lin Bingliang, Third Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01322906     History of Changes
Other Study ID Numbers: ABMS-LF
Study First Received: March 24, 2011
Last Updated: April 8, 2011
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on June 18, 2013