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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00348114
First Posted: July 4, 2006
Last Update Posted: July 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Singapore Eye Research Institute
Information provided by:
Singapore National Eye Centre
  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
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).

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 3, 2006
First Posted: July 4, 2006
Last Update Posted: July 4, 2006
Last Verified: January 2002

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