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| Sponsors and Collaborators: |
Singapore National Eye Centre Singapore Eye Research Institute |
|---|---|
| Information provided by: | Singapore National Eye Centre |
| ClinicalTrials.gov Identifier: | NCT00348114 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Ocular Surface Disease |
Procedure: Transplantation of cultivated limbal epithelium |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD). |
| Estimated Enrollment: | 8 |
| Study Start Date: | May 2002 |
| Estimated Study Completion Date: | May 2006 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | R260/05/2002 |
| Study First Received: | July 3, 2006 |
| Last Updated: | July 3, 2006 |
| ClinicalTrials.gov Identifier: | NCT00348114 |
| Health Authority: | Singapore: Health Sciences Authority |
|
autologous transplantation ex-vivo expanded limbal epithelium limbal deficiency |
