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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Singapore Eye Research Institute
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00348114
First received: July 3, 2006
Last updated: NA
Last verified: January 2002
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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).

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • Snellen visual acuity
  • corneal epithelial integrity and stability

Secondary Outcome Measures:
  • extent of retarding recurrent neovascularisation

Estimated Enrollment: 8
Study Start Date: May 2002
Estimated Study Completion Date: May 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348114

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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00348114     History of Changes
Other Study ID Numbers: R260/05/2002
Study First Received: July 3, 2006
Last Updated: July 3, 2006
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore National Eye Centre:
autologous
transplantation ex-vivo expanded limbal epithelium
limbal deficiency

ClinicalTrials.gov processed this record on May 19, 2013