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

Sponsor
Singapore National Eye Centre (Other)
Overall Status
Suspended
CT.gov ID
NCT00348114
Collaborator
Singapore Eye Research Institute (Other)
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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
  • Procedure: Transplantation of cultivated limbal epithelium
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

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 1, 2002
Study Completion Date :
May 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Snellen visual acuity []

  2. corneal epithelial integrity and stability []

Secondary Outcome Measures

  1. extent of retarding recurrent neovascularisation []

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years and Older
Sexes Eligible for Study:
All
Accepts 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

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

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00348114
Other Study ID Numbers:
  • R260/05/2002
First Posted:
Jul 4, 2006
Last Update Posted:
Jul 4, 2006
Last Verified:
Jan 1, 2002

Study Results

No Results Posted as of Jul 4, 2006