Mouth cells could bring sight back to the blind
NCT ID NCT03949881
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Ophthalmology department, Edouard Herriot hospital, Hospices Civils de Lyon
RECRUITINGLyon, 69003, France