Behcet's Syndrome, Retinitis
Conditions
Keywords
Retinal Vasculitis, Retinal Edema, Behcet's Disease
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.
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | 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 |
Countries
Iran