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

March 24, 2011
April 8, 2011
March 2011
November 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01322906 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)
Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by HBV

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Failure
  • 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).
Group A
Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Interventions:
  • Other: Group 1
  • Other: Group 2
  • Other: Group 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
July 2012
November 2011   (final data collection date for primary outcome measure)

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.
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01322906
ABMS-LF
Yes
Lin Bingliang, Third Affiliated Hospital, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Not Provided
Sun Yat-sen University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP