Overview

This trial is active, not recruiting.

Condition liver cirrhosis
Treatments autologous bmscs transplantation, conserved therapy
Phase phase 2
Sponsor Sun Yat-sen University
Start date October 2009
End date October 2010
Trial size 60 participants
Trial identifier NCT00993941, 1-Bingliang

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Thirty of the enrolled patients were randomly assigned to Group A were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
conserved therapy
Oral or intravenous administration
(Experimental)
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.
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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.

Additional Information

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
Principal investigator Lin B liang, MD/PHD
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.