Status unknownNCT01499459Updated Mar 22, 2012

Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

An interventional study of autologous mesenchymal stem cell transplantation in Liver Cirrhosis, sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-03-22.

Sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 25
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Liver Cirrhosis

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Keywords

liver cirrhosis
autologous mesenchymal stem cell transplantation

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 25 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

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Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi is the lead sponsor of 65 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 25 participants (estimated)

Study arms

Experimental
autologous mesenchymal stem cell transplantation
Genetic: autologous mesenchymal stem cell transplantation

Interventions

Geneticautologous mesenchymal stem cell transplantation
Every patient is given 1x106 MSCs per kg infused via peripheral vein.

What researchers measure

Primary outcomes

clinical improvement
biochemical and hematologic parameters
Time frame: clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation

Secondary outcomes

liver regeneration
histopathologic assesments comparing before and at 6th month liver biopsies
Time frame: 6.th month after MSC transplantation

Study locations

1 site

Gulhane Military Medical Academy Department of Gastroenterology
Ankara, 06018, Turkey

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01499459
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Responsible party: Murat Kantarcioglu (Gulhane Military Medical Academy, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi) — Principal investigator
First posted: Dec 26, 2011
Start date: Jun 2008
Primary completion: Jul 2012 (estimated)
Completion: Aug 2012 (estimated)
Last update: Mar 22, 2012

Study contacts

murat kantarcioglu, MD

principal investigator · Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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