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Autologous Bone Marrow Stem Cells in Cirrhosis Patients

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ClinicalTrials.gov Identifier: NCT00713934
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : October 4, 2011
Sponsor:
Collaborators:
Small Business Developing Center
Shiraz University of Medical Sciences
Information provided by (Responsible Party):
Royan Institute

Tracking Information
First Submitted Date  ICMJE July 9, 2008
First Posted Date  ICMJE July 14, 2008
Last Update Posted Date October 4, 2011
Study Start Date  ICMJE January 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2008)
  • Liver function test [ Time Frame: 6 months ]
  • MELD score [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00713934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2008)
Cirrhosis mortality [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Stem Cells in Cirrhosis Patients
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Stem Cell Transplantation
  • Cirrhosis
Intervention  ICMJE
  • Biological: CD133
    portal vein infusion of CD133+ cells
  • Biological: BM-MNC
    portal vein infusion of BM-MNC
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: CD133
  • Experimental: 2
    Intervention: Biological: BM-MNC
Publications * 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. doi: 011141/AIM.004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2008)
7
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00713934
Other Study ID Numbers  ICMJE Liver-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royan Institute
Study Sponsor  ICMJE Royan Institute
Collaborators  ICMJE
  • Small Business Developing Center
  • Shiraz University of Medical Sciences
Investigators  ICMJE
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
PRS Account Royan Institute
Verification Date March 2010

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