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

July 3, 2006 updated by: Singapore National Eye Centre

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

8

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Snellen visual acuity
corneal epithelial integrity and stability

Secondary Outcome Measures

Outcome Measure
extent of retarding recurrent neovascularisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore National Eye Centre

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

July 3, 2006

First Submitted That Met QC Criteria

July 3, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

July 4, 2006

Last Update Submitted That Met QC Criteria

July 3, 2006

Last Verified

January 1, 2002

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R260/05/2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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