Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

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: NCT00550498
Recruitment Status : Terminated (No improvement obtained in 3 cases. Retinal detachment observed in 2 cases)
First Posted : October 30, 2007
Last Update Posted : November 10, 2015
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Brief Summary:
The purpose of this study is to find if autologous stem cell transplantation can stop the progression of intractable eye lesions of Behcet's Disease or even to improve it.

Condition or disease Intervention/treatment Phase
Retinitis Behcet's Syndrome Biological: Autologous Stem Cell Transplantation Phase 1

Detailed Description:
To test in a pilot study the effect of autologous stem cell transplantation in stopping the progression of retinal damage of eye lesions in Behcet's Disease by repairing the vascular damage, and possibly to improve the lesions.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Bone Marrow - Derived Stem Cell in the Treatment of Ocular Lesions of Behcet's Disease
Study Start Date : December 2007
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: A
Behcet's Disease with ocular lesions
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 3-5 million cells, in a maximum volume of 0.3 ml. Cells will be injected in vitreal at 3.5 millimeter of limbus with a 26 gauge insulin needle.

Primary Outcome Measures :
  1. 1- Visual acuity by ETDRS (Early Treatment of Diabetic Retinopathy Study). 2- Retinal state and retinal edema by Color Photography, Multifocal Electroretinography, and OCT (Optic Coherent Tomography). [ Time Frame: 12 months ]

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Behcet's Disease
  • Fulfilling the International Criteria for behcet's Disease (ICBD)
  • Ocular lesions with retinal vasculitis
  • Resistant to at least 3 months of combination therapy with pulse cyclophosphamide (1g/monthly), azathioprine (3 mg/kg/daily), and prednisolone 0.5 mg/kg/daily
  • Visual acuity not less than 4 meters finger count
  • Retinal edema confirmed by color photography and OCT

Exclusion Criteria:

  • No Vision
  • Active posterior uveitis
  • Fundus not visible

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): NCT00550498

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
Study Chair: Fereydoun Davatchi, MD Rheumatology Research Center, Medical Sciences/University of Teheran
Principal Investigator: Hormoz Shams, MD Rheumatology Research Center, Medical Sciences/University of Tehran
Principal Investigator: Behrouz Nikbin, MD Department of Immunology, Medical Sciences/University of Tehran

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tehran University of Medical Sciences Identifier: NCT00550498     History of Changes
Other Study ID Numbers: 3086
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by Tehran University of Medical Sciences:
Retinal Vasculitis
Retinal Edema
Behcet's Disease

Additional relevant MeSH terms:
Behcet Syndrome
Retinal Diseases
Eye Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Uveal Diseases
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular