Transplantation of Autologous Mesenchymal Stem Cell in Decompensate Cirrhotic Patients With Pioglitazone

This study is currently recruiting participants.

Verified February 2010 by Royan Institute

Sponsor:

Information provided by (Responsible Party):

Royan Institute

ClinicalTrials.gov Identifier:

NCT01454336

First received: October 15, 2011

Last updated: December 25, 2012

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2011

Last Updated Date

December 25, 2012

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

ALT [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Evaluation of ALT levels during 12 months
AST [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Evaluation of AST levels after intervention during 12 months
Serum Albumin [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
The evaluation of serum albumin levels for 12 months
Liver Fibrosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
The decrease in grade of liver fibrosis

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01454336 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression of fibrosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Evaluation of fibrosis based on fibroscan and biopsy and scoring

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Transplantation of Autologous Mesenchymal Stem Cell in Decompensate Cirrhotic Patients With Pioglitazone

Official Title ^ICMJE

Phase 1 Trial of Combined Pioglitazone Plus Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Patients With Compensated Cirrhosis

Brief Summary

Liver cirrhosis (LC) is the final destiny in chronic liver disease. Liver transplantation is the only effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial considerations are it`s essential problems. The immuomodulatory impact of MSCs in fibrosis was confirmed, and several clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research the investigators will study the affect of MSCs and Pioglitazone in the process of fibrosis.

Detailed Description

BM Aspiration will be done twice (6 months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. MNCs will be cultured in T150 flasks. Cells will be expanded in several subcultures.MSCs will be injected (6 months interval) via portal vein under sonography monitoring.Each patient will receive 30mg Pioglitazone daily for 24 months. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Liver Fibrosis

Intervention ^ICMJE

Biological: Cell injection

MSCs introduced into portal vein

Study Arm (s)

Experimental: Cirrhotic Patients

3 cirrhotic patients who underwent a combination of cell therapy and chemotherapy

Intervention: Biological: Cell injection

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18-65 Years cirrhotic patient
Approved cirrhosis by elastografy ,biopsy, sonography

Exclusion Criteria:

1 - Portal vein thrombosis 2-Hepatic encephalopathy, score 3&4 3-ALT & AST 3times more than normal 4-Serum Cr more than 1/5mg/dL 5-(Anti-HIV +) (Anti-HCV+) (HBS-Ag+) 6-Hepatocel carcinoma 7- Primary sclerosing cholangitis (PSC) 8- Esophageal varices grade 4 9-Addiction 10-Child Score B,C

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nasser Aghdami, MD,PhD	(+98)2122339913	nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD	(+98)2122339951	leila.arab@yahoo.com

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01454336

Other Study ID Numbers ^ICMJE

Royan-liver-003

Has Data Monitoring Committee

Yes

Responsible Party

Royan Institute

Study Sponsor ^ICMJE

Royan Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Hamid Gourabi, PhD	Head of Royan Institute
Study Director:	Reza malekzadeh, MD	Director of DDRC
Principal Investigator:	Massoud vosough, MD,PhD	Royan regenerative medicine

Information Provided By

Royan Institute

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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