Stem Cell Transplantation in Ocular Lesions of Behcet's Disease
Phase 1
Terminated
- Conditions
- Behcet's SyndromeRetinitis
- Interventions
- Biological: Autologous Stem Cell Transplantation
- Registration Number
- NCT00550498
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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
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Exclusion Criteria
- No Vision
- Active posterior uveitis
- Fundus not visible
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Autologous Stem Cell Transplantation Behcet's Disease with ocular lesions
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
🇮🇷Tehran, Iran, Islamic Republic of