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

Phase 2

• Conditions: Liver Cirrhosis
• Interventions: Drug: Conserved therapy; Procedure: Autologous BMSCs transplantation

• Registration Number: NCT00993941
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study Start: 2009-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Primary Completion: 2010-10
• Last Update Submitted: 2010-12-03
• Last Update Posted: 2010-12-06
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A(conserved therapy )	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.
Group B (BMSC Transplantion)	Autologous BMSCs transplantation	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.

Primary Outcome Measures

Name	Time	Method
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.	pre-transplantation, and 1week to 1 year post-transplantation

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China