Autologous Mesenchymal Stem Cell Transplantation in Liver... | NCT01499459

Studies
Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

NCT01499459

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Status

Unknown status

Last Update Posted

Mar 22, 2012Estimated

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Liver Cirrhosis

Interventions

autologous mesenchymal stem cell transplantation

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1111111	Other Identifier	Gulhane School of Medicine

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jul 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Dec 14, 2011

First Submission Date that Met QC Criteria

Dec 22, 2011

First Posted Date

Dec 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2012

Last Update Posted Date

Mar 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Murat Kantarcioglu, Gulhane Military Medical Academy, Saglik Bilimleri Universitesi Gulhane Tip FakultesiPrincipal Investigator

Lead Sponsor

Saglik Bilimleri Universitesi Gulhane Tip FakultesiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
autologous mesenchymal stem cell transplantation	Experimental		Genetic: autologous mesenchymal stem cell transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
autologous mesenchymal stem cell transplantation	Genetic	Every patient is given 1x106 MSCs per kg infused via peripheral vein.	autologous mesenchymal stem cell transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical improvement	biochemical and hematologic parameters	clinical improvement parameters will be assessed six month after mesenchymal stem cell transplantation

Secondary Outcomes

Measure	Description	Time Frame
liver regeneration	histopathologic assesments comparing before and at 6th month liver biopsies	6.th month after MSC transplantation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
murat kantarcioglu, MD	Saglik Bilimleri Universitesi Gulhane Tip Fakultesi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gulhane Military Medical Academy Department of Gastroenterology		Ankara		06018	Turkey (Türkiye)

Type	Date	Date Unknown
Release	Jul 3, 2013
Reset	Sep 9, 2013
Release	Jan 5, 2014
Reset	Feb 15, 2014
Release	May 7, 2014
Reset	Jun 5, 2014
Release	Nov 14, 2014
Reset	Nov 20, 2014
Release	Dec 19, 2014
Reset	Jan 6, 2015

Submission Tracking

Estimated Results First Submitted Date

Jul 3, 2013

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 3, 2013			Sep 9, 2013
Jan 5, 2014

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

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Browse Branches

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