Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID03949881

Cultured Autologous Oral Mucosa Epithelial Sheet for the Treatment of Bilateral Limbal Stem Cell Deficiency FEMJA

Led by Hospices Civils de Lyon · Updated on 2025-12-16

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new treatment for total bilateral limbal stem cell deficiency (LSCD), a rare eye condition caused by severe burns or other ocular diseases that lead to blindness and poor quality of life. This condition results in loss of corneal epithelial stem cells, causing conjunctival invasion and corneal clouding. Currently, no proven effective treatments exist for total bilateral LSCD, and existing options have significant limitations and risks. The study involves transplantation of cultivated autologous oral mucosal epithelial sheets (FEMJA) directly onto the corneal stroma without sutures. The sheets adhere strongly and rapidly, protected by a soft contact lens during healing for 3 to 15 days. If the corneal stroma remains opaque due to scars, a complementary corneal graft may be performed 12 months after the FEMJA transplantation. This trial builds on earlier phase I/II studies that showed safety and effectiveness using a different culture method. Participants will have their oral mucosa cells cultured into epithelial sheets using a new enzymatic detachment process and grafted onto the eye. Researchers will monitor visual acuity improvement, transplant success, adverse events, and changes in eye signs and symptoms over 24 months. Safety assessments include monitoring for corneal graft rejection and correlations between biological characteristics of the transplanted sheets and visual outcomes. The total follow-up period is 24 months after transplantation.

CONDITIONS

Brief Title

Cultured Autologous Oral Mucosa Epithelial Sheet for the Treatment of Bilateral Limbal Stem Cell Deficiency

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 65 18 years
  • Signed and dated informed consent for participation in the study
  • Total bilateral limbal stem-cell deficiency
  • Condition caused by thermal or chemical burn, cornea transplantation, or other bilateral ocular surface disorders
  • Severe loss of vision (less than 2/10 on decimal scale or EDTRS)
  • Covered by a social security system
Not Eligible

You will not qualify if you...

  • Eye inflammation
  • Strictly unilateral ocular affliction
  • Acute systemic infection detected by C Reactive Protein rate
  • History of acute ocular inflammation within the past year
  • History of neoplastic disease
  • Glaucoma with intraocular pressure 65 22 mmHg
  • Total symblepharon preventing eye opening
  • Hypersensitivity or allergy to antibiotics or serum
  • Pregnant or breastfeeding women
  • Active infectious diseases such as HBV, HCV, HIV, HTLV-1, or syphilis
  • Ineligible as judged by investigator
  • Less than one year since chemical or thermal burns
  • Under judicial protection
  • Contraindications to anesthesia or fluorescein
  • Oral mucosa, pharynx, or larynx tumors
  • Fungal or viral infection in ENT area
  • Bacterial infection of oral mucosa, pharynx, or larynx
  • Hypersensitivity to ofloxacin, fluorometholone, betamethasone, or certain eye drop excipients
  • Phenylketonuria
  • Uncontrolled psychotic states
  • Recent live vaccination
  • Eye infections including bacterial, fungal, mycobacterial, or certain viral infections
  • Treatment with Class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, or antipsychotics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Healing period between 3 to 15 days according to tolerance, with possible additional corneal allograft 12 months after transplantation if needed.

Participants receive a cultured autologous oral mucosa epithelial sheet grafted onto the corneal stroma without sutures, followed by protection with a soft permanent contact lens during healing.

1 day for transplantation and healing follow-up visits as tolerated

Follow-up

Duration - Up to 24 months after FEMJA transplantation

Participants are monitored for improvements in visual acuity, physical signs, neovascularization, symptoms, adverse events, and corneal graft rejection.

Assessments at 6, 12, 18, and 24 months after transplantation

Trial Site Locations

Total: 1 location

1

Ophthalmology department, Edouard Herriot hospital, Hospices Civils de Lyon

Lyon, France, 69003

Actively Recruiting

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Research Team

C

Carole BURILLON, MD

C

Celine AUXENFANS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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