Ocular Surface Disease Clinical Trial
Official title:
Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD).
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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