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Status unknownNCT00993941Updated Dec 6, 2010

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

A Phase 2 interventional study of Autologous BMSCs transplantation and Conserved therapy in Liver Cirrhosis, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-12-06.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Liver Cirrhosis

Keywords

  • BMSC
  • Stem cells
  • Liver cirrhosis
  • Transplantation
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Group A(conserved therapy )

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

    Drug: Conserved therapy

  • Experimental
    Group B (BMSC Transplantion)

    Thirty of the enrolled patients were randomly assigned to Group B were received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as Bone Mesenchymal Stem Cells(BMSC) transplantation via portal vein.

    Procedure: Autologous BMSCs transplantation

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: pre-transplantation, and 1week to 1 year post-transplantation

07

Study locations

1 site
  • Sun Yat-sen University
    Guangzhou, Guangdong, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00993941
Lead sponsor
Sun Yat-sen University
First posted
Oct 14, 2009
Start date
Oct 2009
Primary completion
Oct 2010 (estimated)
Completion
Apr 2011 (estimated)
Last update
Dec 6, 2010

Study contacts

Lin B liang, MD/PHD
principal investigator · SunYat-sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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