EUCTR2010-024409-11-GBActive, not recruitingPhase 1
Pilot Clinical Assessment of Ex Vivo Expanded Corneal Limbal Stem Cell Transplantation in Patients with Severe Ocular Surface Disease (OSD) Arising from Limbal Stem Cell Deficiency
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Adult patients, of either sex, with bilateral corneal blindness due to limbal stem cell deficiency
- •- Visual acuity less than 3/60 in the better eye
- •- Severe, debilitating corneal disease with extremely low chance of successful outcome with limbal and corneal graft surgery
- •- Functioning retina indicated by light perception and ultra-sonographic examination to exclude retinal detachment
- •- Normal intra-ocular pressure
- •- Schirmer’s test at least 50% normal values
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- Inability to give informed, comprehending consent
- •- Unfitness for local or general anaesthesia
- •- Inability to self-administer medication
- •- Inability to tolerate immunosuppressive therapy
- •- Severe dry eyes
- •- Patients with corneal anaesthesia
- •- Patients with severe lid deformities
- •- Patients with uncontrolled glaucoma or drainage procedures
Investigators
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