Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 1 Study of Bone Marrow - Derived Stem Cell in the Treatment of Ocular Lesions of Behcet's Disease

Conditions
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Retinitis, Behcet's Syndrome

Intervention / Treatment
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* Biological: Autologous Stem Cell Transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Behcet's Disease with ocular lesions | Biological: Autologous Stem Cell Transplantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinal Vasculitis, Retinal Edema, Behcet's Disease