CClinicalTrials.gg
Status unknownNCT01322906Updated Apr 11, 2011

Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by Hepatitis B Virus (HBV)

A Phase 2 interventional study of Group 1 and Group 2 in Liver Failure, sponsored by Sun Yat-sen University. Status unknown. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-04-11.

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this record recently (last verified Oct 2010), so the status shown — last known as Active, not recruiting — may be out of date.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
120
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study summary

Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients with Liver Failure Caused by hepatitis B virus (HBV)

02

Conditions studied

  • Liver Failure

Keywords

  • ABMLF
  • 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 120 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

  • Liver failure caused by HBV
  • Model for End-Stage Liver Disease (MELD) \< 30

Exclusion criteria

Exclusion Criteria:

  • Liver Failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on.
  • History of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment.
  • Severe problems in other vital organs (e.g.the heart,renal or lungs).
  • Tumor on ultrasonography, CT or MRI examination.
  • Pregnant or lactating women.
  • HIV infection.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Other
    Group A

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

    Other: Group 1 · Other: Group 2 · Other: Group 3

Interventions

  • OtherGroup 1

    Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(2×105/Kg, once a week, 4 times).

  • OtherGroup 2

    Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(1×106/Kg, once a week, 4 times).

  • OtherGroup 3

    Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(5×106/Kg, once a week, 4 times).

06

What researchers measure

Primary outcomes

  1. Liver Function

    The levels of serum alanine aminotransferase (ALT), aspartate aminotransferase(AST),total bilirubin (TB),prothrombin time (PT), prothrombin activity(PTA),INR,albumin (ALB),globulin(GLB), prealbumin(PA),creatinine(Cr), Urea nitrogen(BUN),number of leucocyte,erythrocyte and platelet, cytokines,liver histological

    Time frame: 12months

  2. Immune state

    cytokine

    Time frame: 12months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01322906
Lead sponsor
Sun Yat-sen University
First posted
Mar 25, 2011
Start date
Mar 2011
Primary completion
Nov 2011 (estimated)
Completion
Jul 2012 (estimated)
Last update
Apr 11, 2011

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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