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Autologous Bone Marrow Stem Cells in Cirrhosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00713934
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : October 4, 2011
Small Business Developing Center
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
Royan Institute

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 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 or disease Intervention/treatment Phase
Stem Cell Transplantation Cirrhosis Biological: CD133 Biological: BM-MNC Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: 1 Biological: CD133
portal vein infusion of CD133+ cells

Experimental: 2 Biological: BM-MNC
portal vein infusion of BM-MNC

Primary Outcome Measures :
  1. Liver function test [ Time Frame: 6 months ]
  2. MELD score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Cirrhosis mortality [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00713934

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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
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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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Royan Institute Identifier: NCT00713934     History of Changes
Other Study ID Numbers: Liver-001
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: March 2010
Keywords provided by Royan Institute:
Autologous Bone marrow stem cells
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases