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NCT01223664 Clinical Trial

Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:
The Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis Resulting From Chronic Hepatitis B

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01223664
Other study ID # SYS-1012
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received October 12, 2010
Last updated October 18, 2010
Start date October 2010
Est. completion date November 2011

Study information
Verified date October 2010
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 allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver cirrhosis. 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 November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria:

- Aged 16~65 years.

- Serum HBsAg positive for over six months.

- 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 over 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

Intervention

Procedure:
• Allogenic bone marrow stem cells transplantation
30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy
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 Liver Function 12 months No
Secondary Immunity 12 months No
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