This trial is active, not recruiting.

Condition liver cirrhosis
Treatment autologous mesenchymal stem cell transplantation
Sponsor Gulhane Military Medical Academy
Start date June 2008
End date July 2012
Trial size 25 participants
Trial identifier NCT01499459, 1111111, 11111111


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
autologous mesenchymal stem cell transplantation
Every patient is given 1x106 MSCs per kg infused via peripheral vein.

Primary Outcomes

clinical improvement
time frame: clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation

Secondary Outcomes

liver regeneration
time frame: 6.th month after MSC transplantation

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis
Principal investigator murat kantarcioglu, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Gulhane Military Medical Academy.