RecruitingNAINTERVENTIONAL

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

This research aims to find a new treatment for a condition called Limbal Stem Cell Deficiency (LSCD), where the clear front part of the eye, called the cornea, can't heal itself properly. This can lead to blurry vision. Currently, treatment options are limited and can be risky. This study uses cells from inside your mouth, which are easy to get, and tries to change them into special cells that can repair the cornea. If successful, this could lead to a safer and more effective way to help people with LSCD to see better. The first step for this study is to develop a reliable way to make these special eye cells from mouth cells.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Montpellier

Enrolment target

Start

19 Jun 2024

Estimated completion

01 Jun 2025

Limbal Stem Cell Deficiency

What is this study about?

Imagine the clear front window of your eye, called the cornea. It's really important for letting light in so you can see clearly. This window has a special outer layer that's constantly renewing itself, a bit like your skin. This renewal process relies on tiny, powerful cells called 'stem cells' that live in a ring around the edge of your cornea.

Sometimes, these stem cells get damaged or don't work properly. This condition is called Limbal Stem Cell Deficiency (LSCD). When this happens, your cornea can't heal itself, might get cloudy, and your vision can become blurry. Current treatments often involve using tissue from another part of your eye or a donor, but these can have risks.

This study is exploring a new and less risky way to help people with LSCD. Researchers believe that cells from inside your mouth (buccal mucosa) might have the ability to be changed into the special stem cells needed for the cornea. The goal of this particular study is to develop and test a reliable method to make these mouth cells *transform* into replacement corneal stem cells. If they can successfully figure out how to do this, it could pave the way for a brand new treatment in the future.

Key takeaways

This study is researching a new way to treat serious eye problems.
It involves using cells from inside your mouth to create new eye-healing cells.
The aim is to develop a reliable lab method, not direct patient treatment yet.
It could lead to safer, kinder treatments for eye conditions in the future.
Participation involves a simple procedure to collect mouth cells.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. You should have an eye condition that your eye doctor believes might be helped by a procedure involving new tissue for the surface of your eye, such as if you have a recurring growth on your eye, a certain type of eye cancer, or an eye burn.

There are also some reasons why you might not be able to join. These include having certain long-term infections like HIV or hepatitis. You also can't participate if you have any problems with your mouth that the study doctor thinks could affect the cells they need to take. If you have a serious medical condition that isn't under good control, or if you are pregnant or breastfeeding, you wouldn't be able to take part in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have an eye condition that might need a conjunctival reconstruction?
Do you *not* have any serious, untreated infections?
Are you *not* pregnant or breastfeeding?
Do you *not* have any specific mouth problems that a doctor might be concerned about?

Answer every question to see your result.

What does participation involve?

This study is focused on developing a method in the lab right now, not on treating patients directly. If you were eligible and chose to participate, the main thing involved would be giving a small sample of cells from the inside of your mouth. Your full involvement would likely be limited to this initial procedure and any necessary follow-up to ensure your recovery from the cell collection. The cells would then be sent to a special lab in Montpellier, France, for the research. The total duration of your direct participation would likely be minimal.

Potential risks and benefits

Since this is a research study focused on developing a lab process, there are no direct medical benefits for you as a participant. The potential risks would be minor, mainly related to the discomfort or very small risk of infection from taking a small sample of cells from inside your mouth. The overall benefit of this research is for future patients, offering the hope of a safer and more effective treatment for serious eye conditions. You would have the right to withdraw from the study at any time.

Locations (1)

CHU Gui de Chauliac - Service d'Ophtamologie
Verified postcode
Montpellier, France· Recruiting

Common questions

What is the study trying to achieve?

It's trying to find a new way to help repair damaged corneas by seeing if cells from your mouth can be turned into special eye-healing cells.

Will I receive treatment in this study?

No, this study is about developing a new method in the lab, not about treating patients directly yet.

Where do the cells come from?

A small sample of cells would be taken from the inside of your cheek, which is a simple procedure.

Is this a new idea?

Studies have shown this might be possible, but this research is focused on creating a dependable method for it.

Who is running this study?

It's being run by ophthalmology experts at Montpellier University Hospital, with a research team in Montpellier, France.

How to find out more

Vincent Daien, MD PhD

v-daien@chu-montpellier.fr 04 67 33 69 66 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.