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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Qingdao University.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Qingdao University

ClinicalTrials.gov Identifier:

NCT01224327

First received: October 18, 2010

Last updated: October 19, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2010

Last Updated Date

October 19, 2010

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The result of liver function and liver histological improvement. [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01224327 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The disappearance or reduction of abdominal dropsy [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs ) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Liver Cirrhosis
Radiology
Mesenchymal Stem Cells
Umbilical Cord

Intervention ^ICMJE

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 Name: Mesenchymal Stem Cells
Drug: Conserved therapy
Oral or intravenous administration

Other Name: Drug therapy

Study Arm (s)

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.

Intervention: Biological: umbilical cord Mesenchymal Stem Cells
Active Comparator: Conserved therapy
Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Intervention: Drug: Conserved therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jianxia Hu, MD	86-0532-82911676	qdyxyhjx@126.com
Contact: Hong Gao, MS	86-0532-82911676	honggaogloria@gmail.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01224327

Other Study ID Numbers ^ICMJE

MSCHC005

Has Data Monitoring Committee

Yes

Responsible Party

Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University

Study Sponsor ^ICMJE

Qingdao University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Zibin Tian, MD

The Affiliated Hospital of Medical College of Qingdao University

Information Provided By

Qingdao University

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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