Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

NCT ID: NCT02652351

Last Updated: 2016-05-23

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

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.

Detailed Description

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Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Hepatic Cirrhosis.

To investigate the effects of hUC-MSC treatment for Hepatic Cirrhosis, 20 patients with Hepatic Cirrhosis will be enrolled and receive 4 times of hUC-MSC transplantation.

Conditions

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Hepatic Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hUC-MSC treatment

Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Group Type EXPERIMENTAL

Human umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion or Hepatic artery intervention, and repeated every week for four times.

Interventions

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Human umbilical cord mesenchymal stem cells

A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion or Hepatic artery intervention, and repeated every week for four times.

Intervention Type BIOLOGICAL

Other Intervention Names

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hUC-MSC

Eligibility Criteria

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Inclusion Criteria

* The patient who have signed the informed consent document;
* Clinical, radiological, or biochemical evidence of liver cirrhosis.

Exclusion Criteria

* Pregnant women or lactating mothers;
* Patients who have received any anti-inflammatory drugs including herb-drug within 14 days;
* Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment;
* Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
* Abnormal blood coagulation, combine other tumor or special condition;
* Patients who had participated in other clinical trials within three months prior to this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital University of South China

OTHER

Sponsor Role collaborator

Shenzhen Hornetcorn Bio-technology Company, LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gang Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

The second Affiliated Hospital of University of Soth China

Locations

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The second Affiliated Hospital of University of Soth China

Hengyang, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jin S Cao, lab master

Role: CONTACT

+86 0734-53137955

Facility Contacts

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Gang Chen, Professor

Role: primary

0734-8899939 ext. 621

Other Identifiers

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HYK-hepatic cirrhosis

Identifier Type: -

Identifier Source: org_study_id

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