Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium

Recruiting now · Not applicable

Conditions studied: Limbal Stem Cell Deficiency

In brief

Objectives The transparent surface of the eye, called the cornea, plays a crucial role in transmitting light to the retina and in protecting the eye. On its external surface, the cornea is composed of a constantly renewing multistratified epithelium. This mechanism is fueled by stem cells located in the limbus (the transition zone between the cornea and the sclera). Limbal Stem Cell Deficiency (LSCD) is characterized by a decrease or cessation of epithelial renewal and neovascularization of the cornea. Consequently, the cornea loses its integrity and transparency. This visually impairing condition is currently in a therapeutic impasse as only autologous limbal or allogeneic corneal grafts are viable options, but they pose significant risks to patients. Studies have shown that the oral cavity contains stem cells that can be isolated, cultured, and transdifferentiated into limbal stem cells (LSCs). However, to date, these studies are limited, and no protocol has been validated. In this study, the advantage of the accessibility of the oral cavity is used to develop a protocol for differentiating cells from the oral mucosa into limbal stem cells (LSCs) for use in a future clinical trial with patients. Methodology This prospective monocentric study will be conducted on patients from the ophthalmology department of the Montpellier University Hospital who have an indication for conjunctival reconstruction. After obtaining consent from the patients, cells from the oral wall will be sent to the tissue bank of the Montpellier University Hospital, where they will be cultured. Finally, the transdifferentiation steps will be analyzed by the "Eye" research team at the Institute of Neuroscience in Montpellier, which is collaborating on the project. The investigators have established objective factors to assess the success of the developed protocol based on the literature : (i) \> 3% of stem cells in primary cultures, (ii) \<10% aborted colonies, (iii) Expression of LSC markers (Pax6, Krt14, p63).

Key facts

Study ID

NCT06265298

Run by

University Hospital, Montpellier

People needed

4

Starts

2024-06-19

Expected to finish

2025-06-01

Last updated by the study team

2024-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presenting an indication for conjunctival reconstruction using oral mucosa (for example because of a recurrent pterygium, conjunctival carcinoma or ocular burn)
• Written consent to participate in this research

You may not qualify if…

• Chronic infection (HIV, hepatitis, tuberculosis, Lyme disease)
• Oral pathology which could affect the health of the oral mucosa tissue according to the opinion of the investigating doctor
• Uncontrolled systemic disease
• Pregnant or breastfeeding

Where it is running

• CHU Gui de Chauliac - Service d'Ophtamologie — Montpellier, Occitanie, France (enrolling)

Full record on ClinicalTrials.gov

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