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
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2010
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 15, 2011
CompletedFirst Posted
Study publicly available on registry
October 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedMay 13, 2014
February 1, 2010
3.1 years
October 15, 2011
May 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Progression of fibrosis
12 months
Study Arms (1)
Cirrhotic Patients
EXPERIMENTAL3 cirrhotic patients who underwent a combination of cell therapy and chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Years cirrhotic patient
- Approved cirrhosis by elastografy ,biopsy, sonography
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hamid Gourabi, PhD
Head of Royan Institute
- STUDY DIRECTOR
Reza malekzadeh, MD
Director of DDRC
- PRINCIPAL INVESTIGATOR
Massoud vosough, MD,PhD
Royan regenerative medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2011
First Posted
October 19, 2011
Study Start
June 1, 2010
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
May 13, 2014
Record last verified: 2010-02