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

NCT ID: NCT01322906

Last Updated: 2011-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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Conditions

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Liver Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type OTHER

Group 1

Intervention Type OTHER

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).

Group 2

Intervention Type OTHER

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).

Group 3

Intervention Type OTHER

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).

Interventions

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Group 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).

Intervention Type OTHER

Group 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).

Intervention Type OTHER

Group 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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Third Affiliated Hospital, Sun Yat-sen University

Other Identifiers

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ABMS-LF

Identifier Type: -

Identifier Source: org_study_id

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