CClinicalTrials.gg
Status unknownNCT01221454Updated Oct 18, 2010

Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure

A Phase 2 interventional study of Allogenic bone marrow stem cells transplantation and Conserved therapy in Liver Failure, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-10-18.

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

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Active, not recruiting — may be out of date.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
16 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Liver Failure

Keywords

  • ABMSC
  • Allogenic bone marrow mesenchymal stem cells
  • Liver Failure
  • Transplantation
03

In context

Liver Failure

445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.

This study's planned enrollment of 60 is above the median of 43 across 276 interventional studies indexed under Liver Failure.

Browse Liver Failure 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
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 16\~65 years.
  • Serum HBsAg positive for over six months.
  • Meet the diagnostic criteria of liver failure:

Exclusion criteria

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.
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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 assigned to Group A to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

    Drug: Conserved therapy

  • Experimental
    Group B (BMSC Transplantion)

    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

    Procedure: Allogenic bone marrow stem cells transplantation

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months

Secondary outcomes

  1. Immune function

    Time frame: 12 months

07

Study locations

1 site
  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510630, China
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01221454
Lead sponsor
Sun Yat-sen University
First posted
Oct 15, 2010
Start date
Oct 2010
Primary completion
Nov 2011 (estimated)
Completion
Nov 2011 (estimated)
Last update
Oct 18, 2010

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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