Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein

Evaluation the Efficacy and Safety of Autologous Bone Marrow Mesenchymal Stem Cells (MSCs) Transplantation in Patients With Early and Middle Stage of Liver Cirrhosis

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00993941

Enrollment

Registered

2009-10-14

Start date

2009-10-31

Completion date

2011-04-30

Last updated

2010-12-06

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

Conditions

Liver Cirrhosis

Keywords

BMSC, Stem cells, Liver cirrhosis, Transplantation

Brief summary

The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and middle stage of liver cirrhosis on the basis of HBV 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), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement before and 1 week to 1 year after transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.

Interventions

PROCEDUREAutologous BMSCs transplantation

10 ml autologous BMSCs(7\ 8log10 cells/ml) were infused to patients using interventional method via portal vein as well as conserved therapy for group B.

DRUGConserved therapy

Oral or intravenous administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Aged 18\ 60 years. * Serum HBsAg positive. * Ultrasonographic evidences of cirrhosis.

Exclusion criteria

* history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment. * Prothrombin time is less than 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
The levels of serum alanine aminotransferase (ALT), total bilirubin (TB),prothrombin time (PT), albumin (ALB), prealbumin(PA), precollagenⅢ(PCⅢ), collagenⅣ(Ⅳ-C), laminin(LN), hyaluronidase(HN), liver histological improvement.	pre-transplantation, and 1week to 1 year post-transplantation

Countries

China

Outcome results

None listed

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