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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirrhotic Patients | Experimental | 3 cirrhotic patients who underwent a combination of cell therapy and chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell injection | Biological | MSCs introduced into portal vein |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of fibrosis | Evaluation of fibrosis based on fibroscan and biopsy and scoring | 12 months |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Hamid Gourabi, PhD | Head of Royan Institute | Study Chair |
| Reza malekzadeh, MD | Director of DDRC | Study Director |
| Massoud vosough, MD,PhD | Royan regenerative medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royan Institute | Tehran | Iran |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D043182 | Carboxylesterase |
| ID | Term |
|---|---|
| D002265 | Carboxylic Ester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
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| D045762 |
| Enzymes and Coenzymes |