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Human Umbilical Cord Mesenchymal Stem Cells Transplantation for Patients With Decompensated Liver Cirrhosis

NCT ID: NCT01342250

Last Updated: 2011-10-14

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

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Although liver transplantation provide a option to cure patients suffering with decompensated liver cirrhosis this condition, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Bone marrow derived mesenchymal stem cells (BM-MSCs) have been shown to replace hepatocytes in injured liver, effectively rescued experimental liver failure and contributed to liver regeneration, which suggest the novel and promising therapeutic strategy In this study, the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation for patients with decompensated liver cirrhosis will be evaluated.

Detailed Description

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To investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients of decompensated liver cirrhosis.

Conditions

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Liver Cirrhosis

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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Conventional plus hUC-MSCs treatment (low dose)

Group Type EXPERIMENTAL

conventional therapy plus low dose hUC-MSCs treatment

Intervention Type BIOLOGICAL

patients will receive the conventional therapy plus low dose hUC-MSCs treatment

conventional therapy plus hUC-MSCs treatment （medium dose）

Group Type EXPERIMENTAL

conventional therapy plus medium dose hUC-MSCs treatment

Intervention Type BIOLOGICAL

patients will receive conventional therapy plus medium dose hUC-MSCs treatment

conventional therapy plus hUC-MSCs treatment （high dose）

Group Type EXPERIMENTAL

conventional therapy plus high dose hUC-MSCs treatment

Intervention Type BIOLOGICAL

patients will receive conventional therapy plus high dose hUC-MSCs treatment

Interventions

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conventional therapy plus low dose hUC-MSCs treatment

patients will receive the conventional therapy plus low dose hUC-MSCs treatment

Intervention Type BIOLOGICAL

conventional therapy plus medium dose hUC-MSCs treatment

patients will receive conventional therapy plus medium dose hUC-MSCs treatment

Intervention Type BIOLOGICAL

conventional therapy plus high dose hUC-MSCs treatment

patients will receive conventional therapy plus high dose hUC-MSCs treatment

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Written informed consent.
* Aged 18-70 years.
* Decompensated liver cirrhosis, Child-Pugh B/C (7-12 points); or Meld score≦21.
* Expecting lifetime is over 2 months.
* Hepatitis B decompensated liver cirrhosis patients need antiviral therapy.

Exclusion Criteria

* Severe drug allergic history or anaphylaxis.
* Severe problems in other vital organs(e.g. the heart, renal or lungs)
* Severe problems in psychiatric disease,such as Schizophrenia,et al
* Severe bacteria infection.
* Malignancies.
* Alcoholism or drug abuse.
* Plan to have liver transplantation in 3 months.
* Pregnancy
* Candidates who are participating in other study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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No.85 Hospital, Changning, Shanghai, China

OTHER

Sponsor Role collaborator

Shenzhen Beike Bio-Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chengwei Chen

Role: PRINCIPAL_INVESTIGATOR

No.85 Hospital, Changning, Shanghai, China

Locations

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Shanghai Liver Disease Research Center, the Nanjing Military Command (Shanghai 85 Hospital)

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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BKCR-LD-1.0(2010)

Identifier Type: -

Identifier Source: org_study_id