Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06265298

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

Led by University Hospital, Montpellier · Updated on 2024-08-19

4

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Montpellier

Lead Sponsor

I

Institute for Neuroscience Montpellier

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Indication for conjunctival reconstruction using oral mucosa, such as recurrent pterygium, conjunctival carcinoma, or ocular burn
  • Written consent to participate in the research
Not Eligible

You will not qualify if you...

  • Presence of chronic infections such as HIV, hepatitis, tuberculosis, or Lyme disease
  • Oral diseases affecting the health of oral mucosa as determined by the doctor
  • Uncontrolled systemic illnesses
  • Pregnancy or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Gui de Chauliac - Service d'Ophtamologie

Montpellier, Occitanie, France, 34295

Actively Recruiting

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Research Team

V

Vincent Daien, MD PhD

CONTACT

H

Hannah Crowdy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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