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Allogenic Bone Marrow Stem Cells Transplantation in Patients With Liver Cirrhosis

NCT ID: NCT01223664

Last Updated: 2010-10-19

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

2010-10-31

Study Completion Date

2011-11-30

Brief Summary

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The objective of this study is to evaluate the therapeutic efficacy of allogenic bone marrow stem cells (BMSCs) transplantation in patients with liver cirrhosis. 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

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 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 assigned to Group B to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine, as well as bone marrow stem cells transplantation

Group Type EXPERIMENTAL

Allogenic bone marrow stem cells transplantation

Intervention Type PROCEDURE

30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy

Interventions

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Allogenic 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

Intervention Type PROCEDURE

Conserved therapy

Oral or intravenous administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 16\~65 years.
* Serum HBsAg positive for over six months.
* 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 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.
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

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

Related Links

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http://www.zssy.com.cn/

The Third Affiliated Hospital of Sun Yat-sen University

Other Identifiers

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SYS-1012

Identifier Type: -

Identifier Source: org_study_id