Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

Liver Failure Clinical Trial

Official title:

Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Failure Resulting From Chronic Hepatitis B

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01221454
• Other study ID #: SYS-LF
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 12, 2010
• Last updated: October 15, 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 purpose of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver failure caused by hepatitis B 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), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores, MELD 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.

• Meet the diagnostic criteria of liver failure:

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

• Liver Failure

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	The Third Affiliated Hospital of 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	The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), number of leucocyte,erythrocyte and platelet, cytokines, T lymphocyte and B lymphocyte,liver histological	12 months	No
Secondary	Immune function		12 months	No

External Links

•   The Third Affiliated Hospital of Sun Yat-sen University