Transplantation of Cultivated Limbal Epithelium on Amniotic Membrane for Limbal Stem Cell Deficiency
Study Details
Study Description
Brief Summary
To evaluate the effectiveness of autologous (tissue from fellow eye) transplantation of cultivated limbal epithelium on amniotic membrane to treat severe surface irregularity and scarring of the corneal surface.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
The corneal epithelium is under constant cell-turnover,and it has been shown that the limbus is the ultimate source of epithelial renewal. Significant damage to limbal cells causes a disease state called limbal stem cell deficiency(LSCD),characterized by different extents of conjunctival overgrowth onto cornea, vascularization, chronic inflammation, and poor epithelial integrity.
In unilateral LSCD, the damaged corneal surface may be reconstructed using two large segments of healthy limbal tissue (of approximately 6-8mm by 1mm) from the fellow eye in the procedure of conventional limbal transplantation.This may however compromise ocular surface integrity of the healthy eye depending on the amount of donated limbus. In more recent years, it has been possible to "save" limbal tissue by obtaining only a very small limbal biopsy (2mm by 1mm) from the fellow healthy eye which is "expanded" into a viable sheet of limbal cells via laboratory cultivation.This cultivated sheet of cells is transplanted to treat the damaged ocular surface.
This study is a prospective nonrandomized trial which evaluates the efficacy of transplantation of autologous ex-vivo expanded limbal epithelium on intact amniotic membrane for unilateral total limbal stem cell deficiency.
Study Design
Outcome Measures
Primary Outcome Measures
- Snellen visual acuity []
- corneal epithelial integrity and stability []
Secondary Outcome Measures
- extent of retarding recurrent neovascularisation []
Eligibility Criteria
Criteria
Inclusion Criteria:
- unilateral total limbal stem cell deficiency with normal fellow eye, or minimally damaged fellow eye (less than 1/3 limbus affected)
Exclusion Criteria:
- systemic disease affecting both eyes such as Stevens-Johnson syndrome
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Singapore National Eye Centre
- Singapore Eye Research Institute
Investigators
- Principal Investigator: Seng-Ei Ti, FRCS(Ed), Singapore National Eye Centre
- Study Director: Donald TH Tan, FRCS(G), Singapore Eye Research Institute and Singapore National Eye Centre
Study Documents (Full-Text)
None provided.More Information
Publications
- Ti SE, Anderson D, Touhami A, Kim C, Tseng SC. Factors affecting outcome following transplantation of ex vivo expanded limbal epithelium on amniotic membrane for total limbal deficiency in rabbits. Invest Ophthalmol Vis Sci. 2002 Aug;43(8):2584-92.
- Tsai RJ, Li LM, Chen JK. Reconstruction of damaged corneas by transplantation of autologous limbal epithelial cells. N Engl J Med. 2000 Jul 13;343(2):86-93.
- R260/05/2002