Unilateral corneal epithelial stem cell deficiency: Patients who have dysfunction of the entire limbus with almost replaced by conjunctival epithelium, neovascularization and corneal scarring tissue.
Conditions
Interventions
Corneal limbal epithelial tissue is extracted from a patient'
s own healthy eye, and a limbal epithelial cell sheet using human amniotic membrane is produced. The produced sheet is transplanted to the cornea defected corneal epithelial stem-cell
Sponsors
Department of Ophthalmology, Graduate School of Medicine, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Unilateral limbal stem cell deficiency 2) Unilateral corneal surface is covered by conjunctival tissue 3) Regardless of gender, and must be over 20 years old when the subjects agree with this project 4) The signed consent is required
Exclusion criteria
Exclusion criteria: 1) Subjects who are pregnant, plan to become pregnant, or are breast-feeding. 2) Subjects who have systemic infections (HBV, HCV, HIV, HTLV-1) 3) Subjects who have extremely severe dry eye 4) Subjects who has not passed for six months after undergoing the next operation on the eye which is due to be transplanted; conjunctival sac plasty, amnion transplant of sclera, mitomycin-C treatment 5) Subjects who are not unsuitable for this project by some complications (judged by the docter in charge).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the existence of omission of the transplanted cell sheet, expected eye complications, and all adverse events including a laboratory test abnormality | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the area without epithelial defect or conjunctivalization 2. Improved visual acuity 3. Improved corneal opacity 4. Improved corneal neovascularization | — |
Countries
Japan
Contacts
Public ContactTomohiko Usui
Graduate School of Medicine, The University of Tokyo Department of Ophthalmology
Outcome results
None listed