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Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01223664
Enrollment
60
Registered
2010-10-19
Start date
2010-10-31
Completion date
2011-11-30
Last updated
2010-10-19

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

Conditions

Liver Cirrhosis

Keywords

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

Brief summary

The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver cirrhosis. 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

30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy

Oral or intravenous administration

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

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
No

Inclusion criteria

* Aged 16\ 65 years. * Serum HBsAg positive for over six months. * 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 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

MeasureTime frame
Liver Function12 months

Secondary

MeasureTime frame
Immunity12 months

Countries

China

Outcome results

None listed

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