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

Phase 1

Completed

• Conditions: Liver Fibrosis
• Interventions: Biological: Cell injection

• Registration Number: NCT01454336
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2010-02
• Study Start: 2010-06
• Study First Submitted: 2011-10-15
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-19
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2014-05-10
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cirrhotic Patients	Cell injection	3 cirrhotic patients who underwent a combination of cell therapy and chemotherapy

Primary Outcome Measures

Name	Time	Method
ALT	12 months	Evaluation of ALT levels during 12 months
AST	12 months	Evaluation of AST levels after intervention during 12 months
Serum Albumin	12 months	The evaluation of serum albumin levels for 12 months
Liver Fibrosis	12 months	The decrease in grade of liver fibrosis

Secondary Outcome Measures

Name	Time	Method
Progression of fibrosis	12 months	Evaluation of fibrosis based on fibroscan and biopsy and scoring

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of