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

NCT ID: NCT00993941

Last Updated: 2010-12-06

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis

Keywords

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BMSC Stem cells Liver cirrhosis Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Conserved therapy

Intervention Type DRUG

Oral or intravenous administration

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.

Group Type EXPERIMENTAL

Autologous BMSCs transplantation

Intervention Type PROCEDURE

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.

Interventions

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Autologous 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.

Intervention Type PROCEDURE

Conserved therapy

Oral or intravenous administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Sun Yat-sen University

Principal Investigators

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Lin B liang, MD/PHD

Role: PRINCIPAL_INVESTIGATOR

SunYat-sen University

Locations

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Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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1-Bingliang

Identifier Type: -

Identifier Source: org_study_id