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Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic 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: NCT01120925
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : April 28, 2014
University of Tehran
Information provided by (Responsible Party):
Royan Institute

Brief Summary:
Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver transplantation is the sole effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial consideration are it`s crucial problems. The plasticity of stem cells in bone marrow (BM) to differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have applied BMC injection to induce regeneration of myocardium and blood vessels. In this study, the investigators will study safety and feasibility of twice transplantation of Autologous bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through the portal vein in patients with decompensate cirrhosis.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: MNC Biological: CD133 Biological: Control Phase 1 Phase 2

Detailed Description:
BM Aspiration will be done twice (3months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. For separation of CD133+ cells the CliniMACS instrument will be used. Cells are injected twice (3months interval) via portal vein under sonography monitoring. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Therapeutic Outcome of Twice Transplantation of CD133+ and MNC BM Derived Stem Cells in Cirrhotic Patients: Clinical Trial, Double Blind, Phase I/II
Study Start Date : May 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: MNC
Bone marrow derived MNC
Biological: MNC
2-3 X 109 cells in 20ML suspension IPV in 4 min

Experimental: CD133
CD133 derived from Bone marrow
Biological: CD133
5-15 X 106 cells in 20ML suspension IPV

Placebo Comparator: Control
Normal saline with 5% Human Serum Albumin
Biological: Control
Injection of 20 ml Normal saline via IPV

Primary Outcome Measures :
  1. Liver function test [ Time Frame: 6 months ]
    Meld score, Child score

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:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 16-65 Years cirrhotic patient
  • Approved cirrhosis by elastografy ,biopsy, sonography
  • Serum ALT 1/5 times more than normal
  • MELD score 12 or Child score B or C

Exclusion Criteria:

  • Portal vein thrombosis
  • Hepatic encephalopathy, score 3&4
  • ALT & AST 3times more than normal
  • Serum Cr more than 1/5mg/dL
  • (Anti-HIV +) (Anti-HCV+) (HBS-Ag+)
  • Hepatocel carcinoma
  • Primary sclerosing cholangitis (PSC)
  • Esophageal varices grade 4
  • Addiction

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): NCT01120925

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Iran, Islamic Republic of
Gastroenterology and hepatic disease research center
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Royan Institute
University of Tehran
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Study Chair: Hamid Gourabi, PhD Royan Institute
Study Chair: Reza Malekzadeh, MD Gastroenterology and hepatic disease research center
Principal Investigator: Hossein Baharvand, PhD Royan Institute
Principal Investigator: Mohammad Bagheri, MD Gastroenterology and hepatic disease research center
Study Director: Massoud Vosough, MD Royan Institute
Principal Investigator: Nasser Aghdami, MD., PhD Royan Institute

Additional Information:
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Responsible Party: Royan Institute Identifier: NCT01120925     History of Changes
Other Study ID Numbers: Royan-Liver-002
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: April 28, 2014
Last Verified: May 2010
Keywords provided by Royan Institute:
Stem Cells
Bone marrow stem cells
Decompensate Cirrhotic Patients
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases