Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)

Phase 2

• Conditions: Liver Failure
• Interventions: Other: Group 1; Other: Group 2; Other: Group 3

• Registration Number: NCT01322906
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure Caused by hepatitis B virus (HBV)

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-10
• Study Start: 2011-03
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Last Update Submitted: 2011-04-08
• Last Update Posted: 2011-04-11
• Primary Completion: 2011-11
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Liver failure caused by HBV
• Model for End-Stage Liver Disease (MELD) < 30

Exclusion Criteria

• Liver Failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on.
• History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment.
• Severe problems in other vital organs (e.g.the heart,renal or lungs).
• Tumor on ultrasonography, CT or MRI examination.
• Pregnant or lactating women.
• HIV infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Group 1	Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Group A	Group 2	Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Group A	Group 3	Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Primary Outcome Measures

Name	Time	Method
Liver Function	12months	The levels of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST),total bilirubin (TB),prothrombin time (PT), prothrombin activity(PTA),INR,albumin (ALB),globulin(GLB), prealbumin(PA),creatinine(Cr), Urea nitrogen(BUN),number of leucocyte,erythrocyte and platelet, cytokines,liver histological
Immune state	12months	cytokine