Text Size

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
  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: Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Gulhane Military Medical Academy:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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
Genders Eligible for Study:   Both
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
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
Gulhane Military Medical Academy
Investigators
Principal Investigator: murat kantarcioglu, MD Gulhane Military Medical Academy
  More Information

No publications provided

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

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

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

ClinicalTrials.gov processed this record on June 18, 2013