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Stem Cell Transplantation in Ocular Lesions of Behcet's Disease

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00550498
Enrollment
5
Registered
2007-10-30
Start date
2007-12-31
Completion date
2013-07-31
Last updated
2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behcet's Syndrome, Retinitis

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

BIOLOGICALAutologous Stem Cell Transplantation

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

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026