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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

October 12, 2010
October 15, 2010
October 2010
November 2011   (final data collection date for primary outcome measure)
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
Liver Function [ Time Frame: Every one month ] [ 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
Complete list of historical versions of study NCT01221454 on ClinicalTrials.gov Archive Site
Immune function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Immune function [ Time Frame: Every one month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure
Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Failure Resulting From Chronic Hepatitis B

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Failure
  • 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
  • Drug: Conserved therapy
    Oral or intravenous administration
  • 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.
    Intervention: Drug: Conserved therapy
  • 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
    Intervention: Procedure: Allogenic bone marrow stem cells transplantation
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
60
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01221454
SYS-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