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Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein

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ClinicalTrials.gov Identifier: NCT00993941
Recruitment Status : Unknown
Verified October 2009 by Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : October 14, 2009
Last Update Posted : December 6, 2010
Sponsor:
Information provided by:
Sun Yat-sen University

Brief Summary:
The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and middle stage of liver cirrhosis on the basis of HBV 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), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Procedure: Autologous BMSCs transplantation Drug: Conserved therapy Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation the Efficacy and Safety of Autologous Bone Marrow Mesenchymal Stem Cells (MSCs) Transplantation in Patients With Early and Middle Stage of Liver Cirrhosis
Study Start Date : October 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group A(conserved therapy )
Thirty of the enrolled patients were randomly assigned to Group A were received 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 randomly assigned to Group B were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as Bone Mesenchymal Stem Cells(BMSC) transplantation via portal vein.
Procedure: Autologous BMSCs transplantation
10 ml autologous BMSCs(7~8log10 cells/ml) were infused to patients using interventional method via portal vein as well as conserved therapy for group B.



Primary Outcome Measures :
  1. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement. [ Time Frame: pre-transplantation, and 1week to 1 year post-transplantation ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18~60 years.
  • Serum HBsAg positive.
  • Ultrasonographic evidences of cirrhosis.

Exclusion Criteria:

  • history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.
  • Prothrombin time is less than 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993941


Locations
China, Guangdong
Sun Yat-sen University
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Lin B liang, MD/PHD SunYat-sen University

Responsible Party: Lin Bingliang, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00993941     History of Changes
Other Study ID Numbers: 1-Bingliang
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: October 2009

Keywords provided by Sun Yat-sen University:
BMSC
Stem cells
Liver cirrhosis
Transplantation

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases