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

R

Royan Institute

Status and phase

Completed
Phase 1

Conditions

Liver Fibrosis

Treatments

Biological: Cell injection

Study type

Interventional

Funder types

Other

Identifiers

NCT01454336
Royan-liver-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

Cirrhotic Patients
Experimental group
Description:
3 cirrhotic patients who underwent a combination of cell therapy and chemotherapy
Treatment:
Biological: Cell injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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