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

Allogeneic Bone Marrow Mesenchymal Stem Cells Transplantation in Patients With Liver Failure Caused by HBV

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01322906
Enrollment
120
Registered
2011-03-25
Start date
2011-03-31
Completion date
2012-07-31
Last updated
2011-04-11

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

Conditions

Liver Failure

Keywords

ABMLF, Allogenic Bone marrow Mesenchymal Stem Cells, Liver Failure, Transplantation

Brief summary

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

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).

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Liver Function12monthsThe 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
Immune state12monthscytokine

Outcome results

None listed

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