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

Tehran University of Medical Sciences1 site in 1 country5 target enrollmentDecember 2007

ConditionsRetinitis Behcet's Syndrome

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Retinitis
Sponsor: Tehran University of Medical Sciences
Enrollment: 5
Locations: 1
Primary Endpoint: 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).
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

July 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tehran University of Medical Sciences

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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