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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

July 9, 2008
October 1, 2011
January 2008
January 2009   (final data collection date for primary outcome measure)
  • Liver function test [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • MELD score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00713934 on ClinicalTrials.gov Archive Site
Cirrhosis mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Autologous Bone Marrow Stem Cells in Cirrhosis Patients
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

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Stem Cell Transplantation
  • Cirrhosis
  • Biological: CD133
    portal vein infusion of CD133+ cells
  • Biological: BM-MNC
    portal vein infusion of BM-MNC
  • Experimental: 1
    Intervention: Biological: CD133
  • Experimental: 2
    Intervention: Biological: BM-MNC
Nikeghbalian S, Pournasr B, Aghdami N, Rasekhi A, Geramizadeh B, Hosseini Asl SM, Ramzi M, Kakaei F, Namiri M, Malekzadeh R, Vosough Dizaj A, Malek-Hosseini SA, Baharvand H. Autologous transplantation of bone marrow-derived mononuclear and CD133(+) cells in patients with decompensated cirrhosis. Arch Iran Med. 2011 Jan;14(1):12-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
February 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00713934
Liver-001
Yes
Royan Institute
Royan Institute
  • Small Business Developing Center
  • Shiraz University of Medical Sciences
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
Royan Institute
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP