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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Sun Yat-sen University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00993941
First received: October 13, 2009
Last updated: December 3, 2010
Last verified: October 2009
History of Changes
  Purpose

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 Intervention Phase
Liver Cirrhosis
 Procedure: Autologous BMSCs transplantation
Drug: Conserved therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
The Third Affiliated Hospital of Sun Yat-sen University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Lin Bingliang, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00993941     History of Changes
Other Study ID Numbers: 1-Bingliang
Study First Received: October 13, 2009
Last Updated: December 3, 2010
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 22, 2013