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

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ClinicalTrials.gov Identifier: NCT01454336
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Royan Institute

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.

Condition or disease Intervention/treatment Phase
Liver Fibrosis Biological: Cell injection Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cirrhotic Patients
3 cirrhotic patients who underwent a combination of cell therapy and chemotherapy
Biological: Cell injection
MSCs introduced into portal vein



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

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

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

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


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



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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


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

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01454336     History of Changes
Other Study ID Numbers: Royan-liver-003
First Posted: October 19, 2011    Key Record Dates
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