Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01221454

Enrollment

Registered

2010-10-15

Start date

2010-10-31

Completion date

2011-11-30

Last updated

2010-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Failure

Keywords

ABMSC, Allogenic bone marrow mesenchymal stem cells, Liver Failure, Transplantation

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.

Interventions

PROCEDUREAllogenic 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

DRUGConserved therapy

Oral or intravenous administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Immune function	12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026