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Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by 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

December 14, 2011
March 20, 2012
June 2008
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01499459 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis
Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cirrhosis
Genetic: autologous mesenchymal stem cell transplantation
Every patient is given 1x106 MSCs per kg infused via peripheral vein.
Experimental: autologous mesenchymal stem cell transplantation
Intervention: Genetic: autologous mesenchymal stem cell transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
August 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01499459
11111111, 1111111
Yes
Murat Kantarcioglu, Gulhane Military Medical Academy
Gulhane Military Medical Academy
Not Provided
Principal Investigator: murat kantarcioglu, MD Gulhane Military Medical Academy
Gulhane Military Medical Academy
March 2012

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