Unilateral Limbic Insufficiency
Conditions
Brief summary
Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using cell culture technics that could permit the biological replacement of damaged ocular surface.
Interventions
PROCEDUREbiological replacement corneal surface
the expanded tissue will be applied to patient to replace the damaged ocular surface
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
principal Inclusion Criteria: * Serious unilateral limbic insufficiency * Normal ophthalmological clinical examination in the opposite eye (biopsied eye)
Exclusion criteria
* one-eyed * serious disorders in palpebral dynamics * bilateral limbic insufficiency, immunological, systemic or local illness like toxical epidermic necrosis or pemphigoid * breastfeeding or pregnancy * positive serology of HIV, VLTH, HVC, HVB, CMV, Trypanosoma Cruzi or Treponema Pallidum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 6 months | visual acuity improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lack of scar tissue in ocular surface | 6 months | — |
| decrease of preexisting corneal vascularization | 6 months | — |
| Improvement in appearance of ocular surface | 6 months | presence of corneal epithelium de novo |
| absence or decrease of corneal conjunctivalization | 6 months | the amount of caliciform cells using impression cytology will be compare between screening and 6 months visit |
| adverse events | 6 months | — |
| Improvement of corneal transparency | 6 months | — |
Countries
Spain
Outcome results
None listed