We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454336
First Posted: October 19, 2011
Last Update Posted: May 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Royan Institute
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • ALT [ Time Frame: 12 months ]
    Evaluation of ALT levels during 12 months

  • AST [ Time Frame: 12 months ]
    Evaluation of AST levels after intervention during 12 months

  • Serum Albumin [ Time Frame: 12 months ]
    The evaluation of serum albumin levels for 12 months

  • Liver Fibrosis [ Time Frame: 12 months ]
    The decrease in grade of liver fibrosis


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


Enrollment: 3
Study Start Date: June 2010
Study Completion Date: July 2013
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454336


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
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

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01454336     History of Changes
Other Study ID Numbers: Royan-liver-003
First Submitted: October 15, 2011
First Posted: October 19, 2011
Last Update Posted: May 13, 2014
Last Verified: February 2010

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