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Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Murat Kantarcioglu, Gulhane Military Medical Academy.
Recruitment status was:  Active, not recruiting
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
  Purpose
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 Intervention
Liver Cirrhosis Genetic: autologous mesenchymal stem cell transplantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis

Resource links provided by NLM:


Further study details as provided by Murat Kantarcioglu, Gulhane Military Medical Academy:

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


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


Estimated Enrollment: 25
Study Start Date: June 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: autologous mesenchymal stem cell transplantation Genetic: autologous mesenchymal stem cell transplantation
Every patient is given 1x106 MSCs per kg infused via peripheral vein.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Murat Kantarcioglu, Gulhane Military Medical Academy
ClinicalTrials.gov Identifier: NCT01499459     History of Changes
Other Study ID Numbers: 11111111
1111111 ( Other Identifier: Gulhane School of Medicine )
Study First Received: December 14, 2011
Last Updated: March 20, 2012

Keywords provided by Murat Kantarcioglu, Gulhane Military Medical Academy:
liver cirrhosis
autologous mesenchymal stem cell transplantation

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

ClinicalTrials.gov processed this record on July 25, 2017