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Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

Primary Purpose

Liver Failure

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Allogenic bone marrow stem cells transplantation
Conserved therapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Failure focused on measuring ABMSC, Allogenic bone marrow mesenchymal stem cells, Liver Failure, Transplantation

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Third Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A(conserved therapy )

Group B (BMSC Transplantion)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immune function

Full Information

First Posted
October 12, 2010
Last Updated
October 15, 2010
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01221454
Brief Title
Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure
Official Title
Efficacy of Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Failure Resulting From Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure
Keywords
ABMSC, Allogenic bone marrow mesenchymal stem cells, Liver Failure, Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A(conserved therapy )
Arm Type
Active Comparator
Arm Description
Thirty of the enrolled patients were assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Arm Title
Group B (BMSC Transplantion)
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Allogenic bone marrow stem cells transplantation
Intervention Description
30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy
Intervention Type
Drug
Intervention Name(s)
Conserved therapy
Intervention Description
Oral or intravenous administration
Primary Outcome Measure Information:
Title
Liver Function
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Immune function
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.zssy.com.cn/
Description
The Third Affiliated Hospital of Sun Yat-sen University

Learn more about this trial

Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

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