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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01454336

Enrollment

Registered

2011-10-19

Start date

2010-06-30

Completion date

2013-07-31

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibrosis

Keywords

MSCs, Pioglitazon, fibrosis, liver

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.

Interventions

BIOLOGICALCell injection

MSCs introduced into portal vein

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Progression of fibrosis	12 months	Evaluation of fibrosis based on fibroscan and biopsy and scoring

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026