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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 10, 2014