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Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

Primary Purpose

Liver Cirrhosis

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

autologous mesenchymal stem cell transplantation

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring liver cirrhosis, autologous mesenchymal stem cell transplantation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gulhane Military Medical Academy Department of Gastroenterology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

autologous mesenchymal stem cell transplantation

Arm Description

Outcomes

Primary Outcome Measures

clinical improvement

biochemical and hematologic parameters

Secondary Outcome Measures

liver regeneration

histopathologic assesments comparing before and at 6th month liver biopsies

Full Information

NCT ID

NCT01499459

First Posted

December 14, 2011

Last Updated

March 20, 2012

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

1. Study Identification

Unique Protocol Identification Number

NCT01499459

Brief Title

Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cirrhosis

Keywords

liver cirrhosis, autologous mesenchymal stem cell transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

autologous mesenchymal stem cell transplantation

Arm Type

Experimental

Intervention Type

Genetic

Intervention Name(s)

autologous mesenchymal stem cell transplantation

Intervention Description

Every patient is given 1x106 MSCs per kg infused via peripheral vein.

Primary Outcome Measure Information:

Title

clinical improvement

Description

biochemical and hematologic parameters

Time Frame

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

Secondary Outcome Measure Information:

Title

liver regeneration

Description

histopathologic assesments comparing before and at 6th month liver biopsies

Time Frame

6.th month after MSC transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

murat kantarcioglu, MD

Organizational Affiliation

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gulhane Military Medical Academy Department of Gastroenterology

City

Ankara

ZIP/Postal Code

06018

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

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