Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

Phase 1

Terminated

• Conditions: Behcet's Syndrome; Retinitis

• 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.

Study Timeline

• Study First Submitted: 2007-10-27
• Study First Submitted QC: 2007-10-27
• Study First Posted: 2007-10-30
• Study Start: 2007-12
• Primary Completion: 2012-07
• Study Completion: 2013-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

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

Exclusion Criteria

• No Vision
• Active posterior uveitis
• Fundus not visible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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

Trial Locations

Locations (1)

Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital); 🇮🇷 Tehran, Iran, Islamic Republic of