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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
  Purpose

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.


Condition Intervention Phase
Liver Fibrosis
 Biological: Cell injection
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Trial of Combined Pioglitazone Plus Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Patients With Compensated Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Progression of fibrosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Evaluation of fibrosis based on fibroscan and biopsy and scoring


Estimated Enrollment: 3
Study Start Date: June 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cirrhotic Patients
3 cirrhotic patients who underwent a combination of cell therapy and chemotherapy
 Biological: Cell injection
MSCs introduced into portal vein

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454336

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

Locations
Iran, Islamic Republic of
Royan Institute Recruiting
Tehran, Iran, Islamic Republic of
Contact: Nasser Aghdami, MD,PhD     (+98)2122339913     nasser.aghdami@royaninstitute.org    
Contact: Leila Arab, MD     (+98)2122339951     leila.arab@yahoo.com    
Principal Investigator: Massoud vosough, MD,PhD            
Sub-Investigator: Mahdi Mohammadnejad, MD            
Sponsors and Collaborators
Royan Institute
Investigators
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
  More Information

No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01454336     History of Changes
Other Study ID Numbers: Royan-liver-003
Study First Received: October 15, 2011
Last Updated: December 25, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
MSCs
Pioglitazon
fibrosis
liver

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
 Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013