Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

NCT ID: NCT01499459

Last Updated: 2012-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous mesenchymal stem cell transplantation

Group Type EXPERIMENTAL

autologous mesenchymal stem cell transplantation

Intervention Type GENETIC

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

Interventions

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autologous mesenchymal stem cell transplantation

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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role lead

Responsible Party

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Murat Kantarcioglu

Gulhane Military Medical Academy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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murat kantarcioglu, MD

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Locations

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Gulhane Military Medical Academy Department of Gastroenterology

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1111111

Identifier Type: OTHER

Identifier Source: secondary_id

11111111

Identifier Type: -

Identifier Source: org_study_id

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