Autologous Bone Marrow Stem Cells in Cirrhosis Patients - Full Text View

Sponsors and Collaborators:	Royan Institute Small Business Developing Center Liver transplant center, Shiraz medical Sciences University
Information provided by:	Royan Institute
ClinicalTrials.gov Identifier:	NCT00713934

Purpose

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 complications, rejection, and high cost are it`s serious problems. The potential for stem cells in bone marrow (BM) to differentiate into hepatocytes cells was recently confirmed. Moreover, BMC transplantation has been performed to treat hematological diseases, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study we will evaluate safety and feasibility of autologous bone marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell transplantation through the portal vein in patients with decompensate cirrhosis.

Condition	Intervention	Phase
Stem Cell Transplantation Cirrhosis	Biological: CD133 Biological: BM-MNC	Phase I Phase II

MedlinePlus related topics: Cirrhosis Liver Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Autologous Transplantation of Bone Marrow Derived CD 133 Positive Stem Cell and Mono Nuclear Cell (MNC) Transplantation in Patients With Decompensate Cirrhosis: Randomized Clinical Trial

Further study details as provided by Royan Institute:

Primary Outcome Measures:

Liver function test [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
MELD score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cirrhosis mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	7
Study Start Date:	January 2008
Study Completion Date:	February 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: CD133 portal vein infusion of CD133+ cells
2: Experimental	Biological: BM-MNC portal vein infusion of BM-MNC

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 blood cells, Low density mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For CD133+ cells separation the CliniMACS instrument will be used. Cells are injected via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 4 weeks, and laboratory data are analyzed for 24 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713934

Locations

Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of, 1665659911
Iran, Islamic Republic of, Fars
Liver Transplant Research Center
Shiraz, Fars, Iran, Islamic Republic of

Sponsors and Collaborators

Royan Institute

Small Business Developing Center

Liver transplant center, Shiraz medical Sciences University

Investigators

Study Chair:	Hamid Gorabi, PhD	Royan institute, Tehran, Iran
Study Chair:	Malekhosseini, MD	Liver Transplantation Research Center, Shiraz, Iran
Principal Investigator:	Hossein Baharvand, PhD	Royan institute, Tehran, Iran
Principal Investigator:	Saman Nikeghbal, MD	Liver Transplantation Research Center, Shiraz, Iran
Study Director:	Nasser Aghdami, MD, PhD	Royan institute, Tehran, Iran

More Information

Additional Information:

Royan Institute This link exits the ClinicalTrials.gov site

Shiraz University Of Medical Sciences, Transplantation Research center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Royan Institute ( Hamid Gourabi/ Chief )
Study ID Numbers:	Liver-001
Study First Received:	July 9, 2008
Last Updated:	February 21, 2009
ClinicalTrials.gov Identifier:	NCT00713934 History of Changes
Health Authority:	Iran: Ministry of Health

Keywords provided by Royan Institute:

Autologous Bone marrow stem cells
Cirrhosis

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Fibrosis
Liver Cirrhosis

Additional relevant MeSH terms:

Liver Diseases
Pathologic Processes
Digestive System Diseases
Fibrosis
Liver Cirrhosis

ClinicalTrials.gov processed this record on May 07, 2009