Status:
COMPLETED
Autologous Bone Marrow Stem Cells in Cirrhosis Patients
Lead Sponsor:
Royan Institute
Collaborating Sponsors:
Small Business Developing Center
Shiraz University of Medical Sciences
Conditions:
Stem Cell Transplantation
Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Liver cirrhosis (LC) is the end stage of chronic liver disease. The liver transplantation is one of the only effective therapies available to such patients. However, lack of donors, surgical complicat...
Detailed Description
BM (200 ml) will be harvested from the iliac crest according to standard procedures under general anesthesia and is collected in plastic bags containing anti coagulant. After precipitation of red bloo...
Eligibility Criteria
Inclusion
- Liver biopsy showing histological Cirrhosis, grade B or C (Child-Pugh score)
- Alkaline phosphatase between 2 X to 3X normal value
- liver Cirrhosis in Sonography study
- Incomplete response to UDCA after 6 months of treatment.
- Negative pregnancy test (female patients in fertile age)
- written consent
Exclusion
- Presence of active hepatic encephalopathy
- Refractory ascites
- Evidences of active autoimmune liver disease (e.g. gamma globulin of more than 2 times of upper limit of normal, and ALT \> 3 times normal in patients with autoimmune hepatitis)
- Hepatocellular carcinoma or other malignancies
- sepsis
- Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
- HIV, HBV or HCV infection
- Cardiac, renal or respiratory failure
- Active thrombosis of the portal or hepatic veins
- INR\>2
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00713934
Start Date
January 1 2008
End Date
February 1 2009
Last Update
October 4 2011
Active Locations (2)
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1
Liver Transplant Research Center
Shiraz, Fars, Iran
2
Royan Institute
Tehran, Tehran Province, Iran, 1665659911