Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

Phase 2

• Conditions: Liver Failure
• Interventions: Drug: Conserved therapy; Procedure: Allogenic bone marrow stem cells transplantation

• Registration Number: NCT01221454
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-15
• Last Update Submitted: 2010-10-15
• Last Update Posted: 2010-10-18
• Primary Completion: 2011-11
• Study Completion: 2011-11

Recruitment & Eligibility

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A(conserved therapy )	Conserved therapy	Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Group B (BMSC Transplantion)	Allogenic bone marrow stem cells transplantation	Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as bone marrow stem cells transplantation

Primary Outcome Measures

Name	Time	Method
Liver Function	12 months	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

Secondary Outcome Measures

Name	Time	Method
Immune function	12 months

Trial Locations

Locations (1)

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China