Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

Tehran University of Medical Sciences

Status and phase: Terminated; Phase 1

Conditions: Behcet's Syndrome; Retinitis

Treatments: Biological: Autologous Stem Cell Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00550498

3086

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

A

Experimental group

Description:

Behcet's Disease with ocular lesions

Treatment:

Biological: Autologous Stem Cell Transplantation