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Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT01499459
Recruitment Status : Unknown
Verified March 2012 by Murat Kantarcioglu, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Recruitment status was:  Active, not recruiting
First Posted : December 26, 2011
Last Update Posted : March 22, 2012
Sponsor:
Information provided by (Responsible Party):
Murat Kantarcioglu, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Genetic: autologous mesenchymal stem cell transplantation Not Applicable

Study Type : Interventional
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis
Study Start Date : June 2008
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: autologous mesenchymal stem cell transplantation Genetic: autologous mesenchymal stem cell transplantation
Every patient is given 1x106 MSCs per kg infused via peripheral vein.




Primary Outcome Measures :
  1. clinical improvement [ Time Frame: clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation ]
    biochemical and hematologic parameters


Secondary Outcome Measures :
  1. liver regeneration [ Time Frame: 6.th month after MSC transplantation ]
    histopathologic assesments comparing before and at 6th month liver biopsies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499459


Locations
Turkey
Gulhane Military Medical Academy Department of Gastroenterology
Ankara, Turkey, 06018
Sponsors and Collaborators
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Investigators
Principal Investigator: murat kantarcioglu, MD Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Responsible Party: Murat Kantarcioglu, Gulhane Military Medical Academy, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
ClinicalTrials.gov Identifier: NCT01499459     History of Changes
Other Study ID Numbers: 11111111
1111111 ( Other Identifier: Gulhane School of Medicine )
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by Murat Kantarcioglu, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi:
liver cirrhosis
autologous mesenchymal stem cell transplantation

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases