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Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients

This study is currently recruiting participants.
Verified May 2010 by Royan Institute
Sponsor:
Collaborator:
University of Tehran
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01120925
First received: May 8, 2010
Last updated: December 25, 2012
Last verified: May 2010
History of Changes
  Purpose

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 Intervention Phase
Liver Cirrhosis
 Biological: MNC
Biological: CD133
Biological: Control
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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, Child score


Secondary Outcome Measures:
  • Cirrhosis Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120925

Contacts
Contact: Nasser Aghdami, MD., PhD 00982122414532 nasser.aghdami@royaninstitute.org
Contact: Massoud Vosough, MD 00982122576034 masvos@yahoo.com

Locations
Iran, Islamic Republic of
Gastroenterology and hepatic disease research center Recruiting
Tehran, Iran, Islamic Republic of, 14114
Contact: Mohammad Bagheri, MD            
Principal Investigator: Leila Abdollahzadeh, MD            
Sponsors and Collaborators
Royan Institute
University of Tehran
Investigators
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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01120925     History of Changes
Other Study ID Numbers: Royan-Liver-002
Study First Received: May 8, 2010
Last Updated: December 25, 2012
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Cirrhotic
Stem Cells
Bone marrow stem cells
Decompensate Cirrhotic Patients

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

ClinicalTrials.gov processed this record on May 22, 2013