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NCT01499459 Clinical Trial

Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:
Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01499459
Other study ID # 11111111
Secondary ID 1111111
Status Unknown status
Phase N/A
First received December 14, 2011
Last updated March 20, 2012
Start date June 2008
Est. completion date August 2012

Study information
Verified date March 2012
Source Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 25
Est. completion date August 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• autologous mesenchymal stem cell transplantation
Every patient is given 1x106 MSCs per kg infused via peripheral vein.

Locations
Country Name City State
Turkey Gulhane Military Medical Academy Department of Gastroenterology Ankara

Sponsors (1)
Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary clinical improvement biochemical and hematologic parameters clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation
Secondary liver regeneration histopathologic assesments comparing before and at 6th month liver biopsies 6.th month after MSC transplantation
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