Severe Ocular Surface Disease (OSD) MedDRA version: 14.1 Level: PT Classification code 10067103 Term: Ocular surface disease System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Ex-vivo Corneal Limbal Stem Cell Product
Pharmaceutical Form: Living tissue equivalent
Other descriptive name: Confluent Allogeneic Limbal Stem Cells
Concentration unit: cm2 square centi
Sponsors
Scottish National Blood Transfusion Service
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Determination of feasibility, efficacy and safety of transplantation of ex vivo expanded corneal limbal stem cells ;Secondary Objective: - Assessment of improvement in vision and quality of the ocular surface - Assessment of comparision of immunosuppression and limbal stem cell transplantation with using immunosuppression and amniotic membrane alone - To generate the data required for reliable sample size calculations for subsequent studies - To evaluate all the practicalities and logistics of the study including the recruitment process, follow-up procedures, data collection and analysis - To obtain information on actual recruitment rate;Primary end point(s): The best visual acuity will be calculated for each patient from all post treatment observations available;Timepoint(s) of evaluation of this end point: The main analysis will take place when patients have finished all follow-ups. An interim analysis will also take place after all patients have completed 9 months of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Ocular surface score – image analysis based evaluation of area of neovascularisation, area of opacity and degree of abnormal fluorescein staining - Quality of Life – as assessed by validated questionnaires VF14 and SF36 - Successful re-establishment of corneal surface after treatment, defined as absence of corneal vascularisation, absence of goblet cells on the cornea surface, absence of persistent epithelial defects, smooth corneal epithelium and no staining with fluorescein, non-fibrotic and normal limbal anatomy - Engraftment of donor cells;Timepoint(s) of evaluation of this end point: The main analysis will take place when patients have finished all follow-ups. An interim analysis will also take place after all patients have completed 9 months of follow-up. | — |
Countries
United Kingdom
Contacts
Public ContactRegulatory Compliance Manager
Scottish National Blood Transfusion Service
Outcome results
None listed