Evaluation the Efficacy and Safety of Autologous Bone Marrow Mesenchymal Stem Cells (MSCs) Transplantation in Patients With Early and Middle Stage of Liver Cirrhosis
Overview
- Phase
- Phase 2
- Intervention
- Conserved therapy
- Conditions
- Liver Cirrhosis
- Sponsor
- Sun Yat-sen University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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.
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
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.
Intervention: Conserved therapy
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.
Intervention: Autologous BMSCs transplantation
Outcomes
Primary Outcomes
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