Transplantation of Cultivated Limbal Epithelium on Amniotic Membrane for Limbal Stem Cell Deficiency
|ClinicalTrials.gov Identifier: NCT00348114|
Recruitment Status : Suspended
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
|Condition or disease||Intervention/treatment||Phase|
|Ocular Surface Disease||Procedure: Transplantation of cultivated limbal epithelium||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD).|
|Study Start Date :||May 2002|
|Estimated Study Completion Date :||May 2006|
- Snellen visual acuity
- corneal epithelial integrity and stability
- extent of retarding recurrent neovascularisation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348114
|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|