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

October 19, 2010 updated by: Qingdao University

The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266003
        • Stem Cell Research Center of Medical School Hospital of Qingdao University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: 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.
Other Names:
  • Mesenchymal Stem Cells
Active Comparator: Conserved therapy
Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Drug: Conserved therapy
Oral or intravenous administration
Other Names:
  • Drug therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The result of liver function and liver histological improvement.
Time Frame: every 4 weeks
every 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The disappearance or reduction of abdominal dropsy
Time Frame: every 4 weeks
every 4 weeks
The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs )
Time Frame: every 4 weeks
every 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao University

Investigators

  • Study Director: Zibin Tian, MD, The Affiliated Hospital of Qingdao University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Estimate)

October 20, 2010

Last Update Submitted That Met QC Criteria

October 19, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSCHC005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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