The Effects of Autologous SLET

Limbal Stem-cell Deficiency Clinical Trial

Official title:

The Effects of Autologous Simple Limbal Epithelial Transplantation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04021875
• Other study ID #: 201904117RINB
• 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

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.

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.

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 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

Related Conditions & MeSH terms

• Limbal Stem-cell Deficiency

Locations

Country	Name	City	State
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 (3)

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.20 — View 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-201 — View 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-Hernández EO, Chodosh J. Autologous simple limbal epithelial transplantation for unilateral limbal stem cell deficien — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of patients with clinical success	Clinical success was 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. Kaplan-Meier survival curves were constructed and survival probability calculated using the SPSS software for statistical computing. Focal recurrences of pannus not progressing to the central cornea were not considered as failures and were evaluated separately.	6 months
Secondary	Visual acuity change	Secondary outcome measures included change from baseline visual acuity at 6 months	6 months