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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Liver Fibrosis

Intervention / Treatment
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* Biological: Cell injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cirrhotic Patients<br>3 cirrhotic patients who underwent a combination of cell therapy and chemotherapy | Biological: Cell injection<br>* MSCs introduced into portal vein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALT | Evaluation of ALT levels during 12 months | 12 months | 
| AST | Evaluation of AST levels after intervention during 12 months | 12 months | 
| Serum Albumin | The evaluation of serum albumin levels for 12 months | 12 months | 
| Liver Fibrosis | The decrease in grade of liver fibrosis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of fibrosis | Evaluation of fibrosis based on fibroscan and biopsy and scoring | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSCs, Pioglitazon, fibrosis, liver