Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Mouth cells could bring sight back to the blind

NCT ID NCT03949881

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new treatment for people who have lost vision in both eyes due to severe burns or rare eye diseases. Doctors take a small sample of cells from the inside of the patient's cheek, grow them into a thin sheet in the lab, and then transplant that sheet onto the damaged eye surface. The goal is to restore a clear cornea and improve vision. The trial involves 40 adults and will check safety and whether eyesight gets better over 24 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female aged ≥ 18 years * Signed and dated informed consent for participation in the study * Total bilateral limbal stem-cell deficiency * Caused by thermal or chemical burn, cornea transplantation, and other bilateral disorders of the ocular surface * Severe loss of vision (\<2/10 on decimal scale or/and EDTRS) * The subject must be covered by a social security system Exclusion Criteria * Eye inflammation * Strictly unilateral ocular affliction * Acute systemic infection, objectified during consultation by the investigator and on the following paraclinical parameter: C Reactive Protein rate * History of acute phase of ocular inflammation in the previous year * History of neoplasic disease * Glaucoma defined as intra ocular pressure (air tonometer and applanation tonometer) ≥ 22mmHg * Total symblepharon (comprising eyelid aperture): impossibility to open the 2 eyes * History of hyper sensibility or allergy to antibiotics or serum * Women who are or may be pregnant or breastfeading * Patients with any active infectious disease (HBV, HCV, HIV, HTLV-1 and syphilis) * Patients who are otherwise ineligible for participation in the study in the opinion of the investigator. * Delay of less than one year after chemical or thermal burns * Person under judicial protection * Contraindication related to anesthesia * Contraindication to fluoresceine * Oral mucosa tumor, pharynx or larynx tumor * Fungal or viral infection of the ENT area * Bacteria infection of the oral mucosa, pharynx or larynx. * Hypersensitivity to ofloxacin (or other quinolone drugs), fluorometholone or betamethasone. * Hypersensitivity to one of the excipients of the eye drops used: Monosodium phosphate, anhydrous disodium phosphate, polysorbate 80, sodium chloride, sodium edetate, polyvinyl alcohol, benzalkonium chloride, hydroxypropylmethylcellulose, hydrochloric acid, sodium hydroxide, lactose, cellulose, crospovidone, aspartam, magnesium stearate, * Phenylketonuria * Psychotic states not yet controlled by treatment; * Vaccination with a live vaccine * Bacterial, fungal, myco-bacterial infection of eye structures. * Some evolving viral infections (including hepatitis, herpes, chickenpox, shingles) or other viral infections of the cornea or conjunctiva (except for a keratitis to Herpes zoster). * Patients treated with Class IA or III antiarrhythmics, tricyclic antidepressants, macrolides and antipsychotics

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Total bilateral limbal cell deficiency are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ophthalmology department, Edouard Herriot hospital, Hospices Civils de Lyon

    RECRUITING

    Lyon, 69003, France