NCT01499459

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

4.1 years

First QC Date

December 14, 2011

Last Update Submit

March 20, 2012

Conditions

Liver Cirrhosis

Keywords

liver cirrhosisautologous mesenchymal stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • clinical improvement

    biochemical and hematologic parameters

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

Secondary Outcomes (1)

  • liver regeneration

    6.th month after MSC transplantation

Study Arms (1)

autologous mesenchymal stem cell transplantation

EXPERIMENTAL
Genetic: autologous mesenchymal stem cell transplantation

Interventions

autologous mesenchymal stem cell transplantationGENETIC

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

autologous mesenchymal stem cell transplantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • alcohol intake in last one year
  • initiation of antiviral medication in last one year
  • systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Military Medical Academy Department of Gastroenterology

Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • murat kantarcioglu, MD

    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gulhane Military Medical Academy

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 26, 2011

Study Start

June 1, 2008

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

TU(1)