Back to resultsTransplantation of Autologous Mesenchymal Stem Cell in Decompensate Cirrhotic Patients With Pioglitazone
Primary Purpose
Liver Fibrosis
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Cell injection
Sponsored by
About this trial
This is an interventional treatment trial for Liver Fibrosis focused on measuring MSCs, Pioglitazon, fibrosis, liver
Eligibility Criteria
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
Sites / Locations
- Royan Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cirrhotic Patients
Arm Description
3 cirrhotic patients who underwent a combination of cell therapy and chemotherapy
Outcomes
Primary Outcome Measures
ALT
Evaluation of ALT levels during 12 months
AST
Evaluation of AST levels after intervention during 12 months
Serum Albumin
The evaluation of serum albumin levels for 12 months
Liver Fibrosis
The decrease in grade of liver fibrosis
Secondary Outcome Measures
Progression of fibrosis
Evaluation of fibrosis based on fibroscan and biopsy and scoring
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01454336
Brief Title
Transplantation of Autologous Mesenchymal Stem Cell in Decompensate Cirrhotic Patients With Pioglitazone
Official Title
Phase 1 Trial of Combined Pioglitazone Plus Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Patients With Compensated Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis
Keywords
MSCs, Pioglitazon, fibrosis, liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cirrhotic Patients
Arm Type
Experimental
Arm Description
3 cirrhotic patients who underwent a combination of cell therapy and chemotherapy
Intervention Type
Biological
Intervention Name(s)
Cell injection
Intervention Description
MSCs introduced into portal vein
Primary Outcome Measure Information:
Title
ALT
Description
Evaluation of ALT levels during 12 months
Time Frame
12 months
Title
AST
Description
Evaluation of AST levels after intervention during 12 months
Time Frame
12 months
Title
Serum Albumin
Description
The evaluation of serum albumin levels for 12 months
Time Frame
12 months
Title
Liver Fibrosis
Description
The decrease in grade of liver fibrosis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Progression of fibrosis
Description
Evaluation of fibrosis based on fibroscan and biopsy and scoring
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamid Gourabi, PhD
Organizational Affiliation
Head of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Reza malekzadeh, MD
Organizational Affiliation
Director of DDRC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Massoud vosough, MD,PhD
Organizational Affiliation
Royan regenerative medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Transplantation of Autologous Mesenchymal Stem Cell in Decompensate Cirrhotic Patients With Pioglitazone
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