Using cultured oral mucosa to treat severe eye conditions
Official title: Cultured Autologous Oral Mucosa Epithelial Sheet for the Treatment of Bilateral Limbal Stem Cell Deficiency FEMJA for " Feuillet Epithélial de Muqueuse Jugale Autologue "
Run by Hospices Civils de Lyon · NCT03949881 · Data updated 2026-11-12
This study is testing whether using skin cells from the inside of the mouth can help people with severe eye conditions regain their vision and improve their quality of life.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | November 13, 2020 |
| Main results expected | May 13, 2031 |
| Study ends | May 13, 2031 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT03949881 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with total bilateral limbal stem cell deficiency caused by severe ocular burns or other related conditions.
✕Probably not a fit
Patients with strictly unilateral ocular afflictions or those with active eye inflammation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of cultured autologous oral mucosa epithelial sheets to treat patients suffering from total bilateral limbal stem cell deficiency, a condition that can lead to blindness. The approach aims to provide a new treatment option for patients who have lost their corneal epithelial stem cells due to severe ocular burns or other rare ocular pathologies. The trial will assess the safety and efficacy of FEMJA transplantation in restoring vision and improving quality of life for affected individuals. Participants will be closely monitored for outcomes related to vision restoration and overall ocular health.
Why it matters
Potential benefit: If successful, this treatment could restore vision and significantly improve the quality of life for patients with total bilateral limbal stem cell deficiency.
How similar studies have gone: While this approach is novel and has not been widely tested, it addresses a significant unmet need in treating a rare condition with limited existing options.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Ophthalmology department, Edouard Herriot hospital, Hospices Civils de Lyon
Lyon, France Recruiting
Study contacts
- Study coordinator: Carole BURILLON, MD
- Email: carole.burillon@chu-lyon.fr
- Phone: 472.11.62.17
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.