Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Royan Institute
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Snellen visual acuity
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and long term outcomes of ex vivo cultured limbal stem cell on amniotic membrane transplantation for corneal surface reconstruction in cases of partial and sever limbal stem cell deficiency.
Detailed Description
Ocular surface is composed of corneal and conjunctival epithelial cells. Normal cornea is essential for normal vision. Defects in renewal and repair of ocular surface as a result of limbal stem cell deficiency are now known to cause varying ocular surface morbidity including persistent photophobia, repeated and persistent surface breakdown and overt conjunctivalisation of the cornea. Restoring ocular health in these eyes has traditionally been frustrating. Ex vivo cultured limbal epithelial stem cells have been used successfully to treat limbal stem cell deficiency. Ex-vivo limbal stem cell allograft transplantation is achieved by harvesting limbal corneal tissue from donor eyes (either matched living relatives or cadaveric donors). The donor stem cells are obtained by excising a small area of the conjunctiva at the limbus and are a minor procedure. The tissue so obtained is then grown in tissue culture and once the cells have multiplied sufficiently, small sheets are transplanted on to the affected eye(s), backed with an amniotic membrane. The surgery is undertaken under either local or general anesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with unilateral limbal stem cell insufficiency and totally corneal vascularization
- •Presence of Goblet cells on the cornea
- •Minimum tear was about 5 mm
- •Minimum duration of deficiency was 3 years
- •Vision was Light Perception
Exclusion Criteria
- •Systemic disease affecting both eyes such as Stevens-Johnson syndrome
Outcomes
Primary Outcomes
Snellen visual acuity
Time Frame: 6 months
corneal epithelial integrity and stability
Time Frame: 6 months
Secondary Outcomes
- Impression cytology(12 months)
- Extent of retarding recurrent neovascularisation(12 months)