Liver CirrhosisNCT01499459
Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis
A study testing autologous mesenchymal stem cell transplantation in people with Liver Cirrhosis, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- autologous mesenchymal stem cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2008to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- alcohol intake in last one year
- initiation of antiviral medication in last one year
- systemic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Military Medical Academy Department of Gastroenterology
Ankara, 06018
About this study
Official title: Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis
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
- Liver Cirrhosis
- Being tested
- autologous mesenchymal stem cell transplantation
- Keywords
- liver cirrhosis, autologous mesenchymal stem cell transplantation
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous mesenchymal stem cell transplantationGenetic
Every patient is given 1x106 MSCs per kg infused via peripheral vein.
| Study group | Role | What they receive |
|---|---|---|
| autologous mesenchymal stem cell transplantation | Experimental | Not described Receives: Genetic: autologous mesenchymal stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical improvement
biochemical and hematologic parameters
Measured: clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation
Secondary outcomes (1)
liver regeneration
histopathologic assesments comparing before and at 6th month liver biopsies
Measured: 6.th month after MSC transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJun 2008
- Primary completionJul 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Kantarcioglu, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- murat kantarcioglu, MD, Principal investigator, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499459
- Sponsor's protocol ID
- 11111111
- Other IDs
- 1111111
- Status last verified
- Mar 2012
- First submitted
- 14 Dec 2011
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Exvivo Expanded Autologous Mesenchymal Stem Cell Transplantation Via Peripheral Vein in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT01499459
- Acronym / sponsor ID
- 11111111
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, autologous mesenchymal stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous mesenchymal stem cell transplantation | Experimental | Genetic: autologous mesenchymal stem cell transplantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- alcohol intake in last one year
- initiation of antiviral medication in last one year
- systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous mesenchymal stem cell transplantationEvery patient is given 1x106 MSCs per kg infused via peripheral vein. | Genetic | autologous mesenchymal stem cell transplantation |
Primary outcome
clinical improvement
Time frame: clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation
biochemical and hematologic parameters
1 secondary outcome
liver regeneration
Time frame: 6.th month after MSC transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
murat kantarcioglu, MD principal investigator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous mesenchymal stem cell transplantation in people with Liver Cirrhosis, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical improvement (time frame: clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.