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Stem Cell Transplantation for the Treatment of Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00550524
Recruitment Status : Unknown
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : October 30, 2007
Last Update Posted : November 22, 2010
Sponsor:
Information provided by:
Tehran University of Medical Sciences

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to find if autologous stem cell transplantation can improve clinical manifestations of knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Autologous Stem Cell Transplantation Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Bone Marrow - Derived Stem Cell for the Treatment of Knee Osteoarthritis
Study Start Date : December 2007
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Knee osteoarthritis
 Biological: Autologous Stem Cell Transplantation
Autologous bone marrow aspiration (20 ml) from iliac crest. Separation of mononuclear cells using ficoll hypaque and culture in 10% fetal bovine serum and Dulbecco modified eagles medium. After confluent stage, detachment of cells with trypsin/EDTA, and subculture. Repeated passages until obtainment of required cell number. Confluent cells of last passage are washed with tyrode solution and incubate with M199 for 60 minutes. Cells are separated using trypsin/EDTA and washed 3 times with M199 and 1% HSA. Precipitate will be diluted with heparinized M199 to make solution with 6×106 cells /ml. Sample will be tested for viability and detection of CD45, CD34, CD90, CD44, CD13, CD105, and CD166 before injection. The number of cells for injection will be between 20-25 million cells; in a maximum volume of 4-6 ml. Cells will be injected in the knee joint with a 21 gauge needle.


Outcome Measures
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Primary Outcome Measures :
  1. 1- Comparison of pain in the injected knee with the controlateral knee 2- Comparison of joint motion of the injected knee with the controlateral knee [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Evaluation of side-effects [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate bilateral knee osteoarthritis

Exclusion Criteria:

  • No infectious or inflammatory arthritis
Contacts and Locations
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Information from the National Library of Medicine

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550524


Locations
Iran, Islamic Republic of
Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Fereydoun Davatchi, MD Rheumatology Research Center, Medical Sciences/University of Teheran
Principal Investigator: Behrouz Nikbin, MD Department of Immunology, Medical Sciences/University of Tehran
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences
ClinicalTrials.gov Identifier: NCT00550524     History of Changes
Other Study ID Numbers: 3087
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: November 22, 2010
Last Verified: November 2010

Keywords provided by Tehran University of Medical Sciences:
Knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases