The Effects of Allogeneic SLET

Limbal Stem-cell Deficiency Clinical Trial

Official title:

The Effects of Allogeneic Simple Limbal Epithelial Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04021134
• Other study ID #: 201904118RINB
• Status: Recruiting
• Start date: July 5, 2019
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2019
• Source: National Taiwan University Hospital
• Contact: Wei-Li Chen, phD
• Phone: +886223123456
• Email: cwlntuh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the effect of allogeneic SLET and re-epithelialization after allogeneic SLET.

Description:

Simple limbal epithelial transplantation (SLET) was introduced in 2012 by Sangwan and coworkers to overcome the issues mainly related to the cost of a GMP-certified product and ease of surgical manipulations that al- lows use of smaller pieces of limbus from the contralateral eye (thus avoiding iatrogenic problems). A completely epithelialized, avascular and stable corneal surface was achieved by 6 weeks and was maintained in all recipient eyes at a mean follow-up of 9.2 ± 1.9 months. Best corrected visual acuity improved from worse than 20/200 in all recipient eyes before surgery to 20/40 or better in four (66.6%) eyes. None of the donor eyes developed any complications.Basu et al. reported autologous SLET on a population of 125 patients which included 65 adults and 60 children suffering from unilateral LSCD. 76% (95/125) of eyes maintained a successful outcome at final follow-up without progressive conjunctivalization, development of persistent epithelial defect, infection, or need for repeat SLET. Survival probability of 80% in adults and 72% in children after 1 year. So far, most of the reports have been about autoSLET, that is, the limbal explants are obtained from the unaffected eye of the same recipient, avoiding immune reaction at the later stage. Also, they demonstrated SLET had promising result both in adults and children. A study by Iyer and coworkers used alloSLET in early stages after ocular chemical injury to achieve rapid epithelialization. Instead of taking the biopsy from the recipient's healthy eye, they took it from a cadaveric donor and performed the SLET. Epithelialization and improved best corrected visual acuity and corneal phenotype were achieved at early stages; however, 7 of 18 eyes had a gradual failure of the allograft, and 5 eyes underwent subsequent limbal autograft. Symblepheron formation involving one to two quadrants was recorded in 3 eyes (16.7%). Visual rehabilitative procedures in the chronic phase of chemical injury, in most instances after alloSLET in the acute stage, did not require any keratoplasties. Unfortunately, most diseases causing limbal deficiency, e.g., surface burns (alkali/ thermal), Stevens-Johnson syndrome, contact lens-related epitheliopathy, and ocular cicatricial pemphigoid, tend to affect both eyes of a patient. Autologous SLET may not be applicable in patients with bilateral eyes involvement. In this study, the effect of allogeneic SLET will be investigated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age between 10 to 90 years old

2. The lesion eye has at least grade 2 limbal stem cell deficiency

3. The lesion eye has limbal stem cell deficiency causing recurrent corneal erosion and neovascularization ingrowth

4. The symptoms last for at least 6 months and do not improve with medication

Exclusion Criteria:

1. The symptoms improve spontaneously or with medication

2. Someone who can not be examined regularly after the operation

3. Poor prognosis

4. Severe lagophthalmos or trichiasis that has not been corrected

5. Ocular infection

Related Conditions & MeSH terms

• Limbal Stem-cell Deficiency

Locations

Country	Name	City	State
Taiwan	Department of Ophthalmology, National Taiwan University Hospital,	Taipei
Taiwan	National Taiwan University Hospital	Taipei	Taiwan, Republic Of China

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Borroni D, Wowra B, Romano V, Boyadzhieva M, Ponzin D, Ferrari S, Ahmad S, Parekh M. Simple limbal epithelial transplantation: a review on current approach and future directions. Surv Ophthalmol. 2018 Nov - Dec;63(6):869-874. doi: 10.1016/j.survophthal.2018.05.003. Epub 2018 May 22. Review. — View Citation

Iyer G, Srinivasan B, Agarwal S, Tarigopula A. Outcome of allo simple limbal epithelial transplantation (alloSLET) in the early stage of ocular chemical injury. Br J Ophthalmol. 2017 Jun;101(6):828-833. doi: 10.1136/bjophthalmol-2016-309045. Epub 2016 Oct 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of patients with clinical success	Clinical success is defined as a completely epithelized, avascular, stable corneal surface. Failure was defined as a recurrence of fibrovascular pannus encroaching on the central cornea, frequent epithelial breakdown or persistent epithelial defects. Focal recurrences of pannus not progressing to the central cornea were not considered as failures and were evaluated separately.	6 months
Secondary	Best corrected visual acuity change	Best corrected visual acuity (BCVA) was measured with Snellen chart preoperatively and at 6 months after the operation.	6 months