Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients

NCT ID: NCT01224327

Last Updated: 2010-10-20

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/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.

Detailed Description

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To investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis. Patients with liver cirrhosis were randomly separated into two groups. Umbilical cord MSCs were infused to patients using interventional method via hepatic artery for One group. After the catheter placed at proper hepatic artery was confirmed by angiography, umbilical cord MSCs were infused slowly for 15-20minutes. The control group accepted conserved therapy.

Conditions

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Liver Cirrhosis Radiology Mesenchymal Stem Cells Umbilical Cord

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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umbilical cord mesenchymal stem cells

Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.

Group Type EXPERIMENTAL

umbilical cord Mesenchymal Stem Cells

Intervention Type BIOLOGICAL

Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.

Conserved therapy

Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Group Type ACTIVE_COMPARATOR

Conserved therapy

Intervention Type DRUG

Oral or intravenous administration

Interventions

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umbilical cord Mesenchymal Stem Cells

Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.

Intervention Type BIOLOGICAL

Conserved therapy

Oral or intravenous administration

Intervention Type DRUG

Other Intervention Names

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Mesenchymal Stem Cells Drug therapy

Eligibility Criteria

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Inclusion Criteria

* Aged 18\~70 years.
* Liver cirrhosis
* written consent

Exclusion Criteria

* The end-stage of liver cirrhosis.
* Severe problems in other vital organs(e.g.the heart,renal or lungs).
* Hepatocellular carcinoma or other malignancies
* Pregnancy
* sepsis
* Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
* Cardiac, renal or respiratory failure
* Active thrombosis of the portal or hepatic veins
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Stem Cell Research Center of Medical School Hospital of Qingdao University

Principal Investigators

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Zibin Tian, MD

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

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Stem Cell Research Center of Medical School Hospital of Qingdao University

Qingdao, Shandong, China

Site Status

Countries

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China

Central Contacts

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Jianxia Hu, MD

Role: CONTACT

86-0532-82911676

Hong Gao, MS

Role: CONTACT

86-0532-82911676

Facility Contacts

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Jianxia Hu, MD

Role: primary

86-0532-82911676

Hong Gao, MS

Role: backup

86-0532-82911676

Other Identifiers

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MSCHC005

Identifier Type: -

Identifier Source: org_study_id