A Clinical Trial to Test a Novel Treatment Using Adult Stem Cells for Transplantation as a Treatment for Eye Disease
- Conditions
- Therapeutic area: Diseases [C] - Eye Diseases [C11]Severe Ocular Surface Disease (OSD)MedDRA version: 14.1Level: PTClassification code 10067103Term: Ocular surface diseaseSystem Organ Class: 10015919 - Eye disorders
- Registration Number
- EUCTR2010-024409-11-GB
- Lead Sponsor
- Scottish National Blood Transfusion Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method