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

Liver Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454336
• Other study ID #: Royan-liver-003
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2011
• Last updated: May 10, 2014
• Start date: June 2010
• Est. completion date: July 2013

Study information

• Verified date: February 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Liver Fibrosis

Intervention

Biological:
• Cell injection
MSCs introduced into portal vein

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALT	Evaluation of ALT levels during 12 months	12 months	Yes
Primary	AST	Evaluation of AST levels after intervention during 12 months	12 months	Yes
Primary	Serum Albumin	The evaluation of serum albumin levels for 12 months	12 months	Yes
Primary	Liver Fibrosis	The decrease in grade of liver fibrosis	12 months	Yes
Secondary	Progression of fibrosis	Evaluation of fibrosis based on fibroscan and biopsy and scoring	12 months	Yes