Skip to content

Transplantation of Cultivated Limbal Epithelium on Amniotic Membrane for Limbal Stem Cell Deficiency

Transplantation of Ex-Vivo Expanded Human Limbal Epithelial Stem Cells (LSC) on Amniotic Membrane (AM) for Limbal Stem Cell Deficiency (LSCD).

Status
Suspended
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00348114
Enrollment
8
Registered
2006-07-04
Start date
2002-05-31
Completion date
2006-05-31
Last updated
2006-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Surface Disease

Keywords

autologous, transplantation ex-vivo expanded limbal epithelium, limbal deficiency

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.

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.

Interventions

PROCEDURETransplantation of cultivated limbal epithelium

Sponsors

Singapore Eye Research Institute
CollaboratorOTHER
Singapore National Eye Centre
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Snellen visual acuity
corneal epithelial integrity and stability

Secondary

MeasureTime frame
extent of retarding recurrent neovascularisation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026