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

Study acronym: TransBuCor
StatusUnknown
PhaseNot applicable
Started2024-06-19
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 19, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Recruiting → Unknown
2024-08-16
notable
Not Yet Recruiting→Unknown Study Status, Study Design, Arms and Interventions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Unknown
Primary completion date2025-02→2025-06
Completion date2025-02→2025-06
Start dateestimated 2024-02→confirmed 2024-06-19
Study sitesdetails revised at 1 of 1 site
2024-02-09
minor
Original filing
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).
Trial Details
NCT Number NCT06265298
Lead Sponsor University Hospital, Montpellier
Collaborators: Institute for Neuroscience Montpellier
Conditions Limbal Stem Cell Deficiency
Enrollment 4 participants
Start Date 2024-06-19
Primary Completion 2025-06 (estimated)
Study Completion 2025-06 (estimated)
Updated on ClinicalTrials.gov 2024-08-19