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Autologous Bone Marrow Stem Cells in Cirrhosis Patients

This study has been completed.
Sponsor:
Collaborators:
Small Business Developing Center
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT00713934
First received: July 9, 2008
Last updated: October 1, 2011
Last verified: March 2010
History of Changes
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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
Experimental: 1 Biological: CD133
portal vein infusion of CD133+ cells
Experimental: 2 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
Liver Transplant Research Center
Shiraz, Fars, Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of, 1665659911
Sponsors and Collaborators
Royan Institute
Small Business Developing Center
Shiraz University of Medical Sciences
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 by Royan Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT00713934     History of Changes
Other Study ID Numbers: Liver-001
Study First Received: July 9, 2008
Last Updated: October 1, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Royan Institute:
Autologous Bone marrow stem cells
Cirrhosis

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013