- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00348114
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).
Study Overview
Status
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
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
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
General Publications
- Ti SE, Anderson D, Touhami A, Kim C, Tseng SC. Factors affecting outcome following transplantation of ex vivo expanded limbal epithelium on amniotic membrane for total limbal deficiency in rabbits. Invest Ophthalmol Vis Sci. 2002 Aug;43(8):2584-92.
- Tsai RJ, Li LM, Chen JK. Reconstruction of damaged corneas by transplantation of autologous limbal epithelial cells. N Engl J Med. 2000 Jul 13;343(2):86-93. doi: 10.1056/NEJM200007133430202.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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