Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Murat Kantarcioglu, Gulhane Military Medical Academy

ClinicalTrials.gov Identifier:

NCT01499459

First received: December 14, 2011

Last updated: March 20, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 14, 2011

Last Updated Date

March 20, 2012

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

clinical improvement [ Time Frame: clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation ] [ Designated as safety issue: No ]

biochemical and hematologic parameters

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01499459 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

liver regeneration [ Time Frame: 6.th month after MSC transplantation ] [ Designated as safety issue: Yes ]

histopathologic assesments comparing before and at 6th month liver biopsies

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

Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

Official Title ^ICMJE

Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis

Brief Summary

This study is aiming to investigate the efficacy of autologous mesenchymal stem cell (MSC) transplantation in 25 randomized patients with liver cirrhosis autologous mesenchymal stem cell will be derived from patients' bone marrows and will be infused via peripheral vein. Liver biopsies will be performed in every patient in the beginning and at 6th month.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Liver Cirrhosis

Intervention ^ICMJE

Genetic: autologous mesenchymal stem cell transplantation

Every patient is given 1x106 MSCs per kg infused via peripheral vein.

Study Arm (s)

Experimental: autologous mesenchymal stem cell transplantation

Intervention: Genetic: autologous mesenchymal stem cell transplantation

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

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2012

Estimated Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

radiological, clinical and histopathological diagnosis of liver cirrhosis
absence of hepatocellular carcinoma or any malignancies
no psychiatric disorder
no serous cardiovascular and pulmonary comorbidities
serum total bilirubin levels less than 5 mg/dL
platelet counts more than 30.000 mm3
more than one year follow up period after initiation of antiviral drugs

Exclusion Criteria:

alcohol intake in last one year
initiation of antiviral medication in last one year
systemic diseases

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT Number ^ICMJE

NCT01499459

Other Study ID Numbers ^ICMJE

11111111, 1111111

Has Data Monitoring Committee

Yes

Responsible Party

Murat Kantarcioglu, Gulhane Military Medical Academy

Study Sponsor ^ICMJE

Gulhane Military Medical Academy

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

murat kantarcioglu, MD

Gulhane Military Medical Academy

Information Provided By

Gulhane Military Medical Academy

Verification Date

March 2012

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

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