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UnknownNCT04021875

The Effects of Autologous SLET

The Effects of Autologous Simple Limbal Epithelial Transplantation.

Status
Unknown
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
10 Years – 90 Years
Healthy volunteers
Not accepted

Summary

This study aims to prospectively evaluate the therapeutic effects of autologous simple limbal epithelial transplantation for patients with limbal stem cell deficiency. The change of visual acuity, quality of life and so on will be monitored before and after surgery.

Detailed description

Human corneal epithelial cells are stratified squamous cells that cover the corneal surface. These cells are regenerated from cells known as limbal stem cells (LSCs) that grow continuously and proliferate from the limbus. Failure or damage at the limbal zone can occur from hereditary or acquired causes such as ocular burns, trauma, or diseases such as Stevens- Johnson syndrome, leading to limbal stem cell deficiency (LSCD). The treatment of LSCD includes transplantation of healthy limbal tissue or cultured limbal epithelial cells. In the last two decades, cultivated limbal epithelial transplantation (CLET) has been a widely used technique. In 2012, Sangwan and coworkers proposed a novel technique that they named simple limbal epithelial transplantation (SLET) for the treatment of unilateral LSCD1. SLET could have benefits for those centers that do not have the ability to perform cultivated limbal epithelial transplantation (CLET) preparation and could be especially useful for those countries that cannot afford a GMP center. Therefore, SLET is quickly gaining popularity in countries like India. As it is a relatively new technique, its long-term clinical effectiveness (similar to what is observed in CLET) must be noted before determining its actual benefits.Our study aims to prospectively evaluate the therapeutic effects of autologous simple limbal epithelial transplantation for patients with limbal stem cell deficiency. The change of visual acuity, quality of life and so on will be monitored before and after surgery. In this study, the effects of autologous simple limbal epithelial transplantation will be investigated.

Conditions

Timeline

Start date
2019-07-05
Primary completion
2020-07-01
Completion
2025-07-01
First posted
2019-07-16
Last updated
2019-07-16

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT04021875. Inclusion in this directory is not an endorsement.