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

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00993941
• Other study ID #: 1-Bingliang
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 13, 2009
• Last updated: December 3, 2010
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: October 2009
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

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.

Drug:
• Conserved therapy
Oral or intravenous administration

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagen?(PC?), collagen?(?-C), laminin(LN), hyaluronidase(HN), liver histological improvement.		pre-transplantation, and 1week to 1 year post-transplantation	Yes