Clinical trial NCT04021875: The Effects of Autologous SLET
Official title: The Effects of Autologous Simple Limbal Epithelial Transplantation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Limbal Stem-cell Deficiency
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with limbal stem cell deficiency

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age 10-90 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. Symptoms improve spontaneously or under medication
2. Someone who can not be examined regularly after the operation
3. Someone with poor prognosis
4. Severe lagophthalmos or trichiasis that has not been corrected
5. Ocular infection

Primary outcomes:
measure: Numbers of patients with clinical success
timeFrame: 6 months
Secondary outcomes:
measure: Visual acuity change
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Taiwan, Republic Of China
Study officials:
affiliation: National Taiwan University Hospital
name: Wei-Li Chen, phD
role: STUDY_CHAIR
References:
citation: Sangwan VS, Basu S, MacNeil S, Balasubramanian D. Simple limbal epithelial transplantation (SLET): a novel surgical technique for the treatment of unilateral limbal stem cell deficiency. Br J Ophthalmol. 2012 Jul;96(7):931-4. doi: 10.1136/bjophthalmol-2011-301164. Epub 2012 Feb 10.
citation: Vazirani J, Ali MH, Sharma N, Gupta N, Mittal V, Atallah M, Amescua G, Chowdhury T, Abdala-Figuerola A, Ramirez-Miranda A, Navas A, Graue-Hernandez EO, Chodosh J. Autologous simple limbal epithelial transplantation for unilateral limbal stem cell deficiency: multicentre results. Br J Ophthalmol. 2016 Oct;100(10):1416-20. doi: 10.1136/bjophthalmol-2015-307348. Epub 2016 Jan 27.
citation: 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.