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

  • STATUS
    Recruiting
  • End date
    May 13, 2025
  • participants needed
    40
  • sponsor
    Hospices Civils de Lyon
Updated on 26 January 2021

Summary

Some severe ocular burns or other rare ocular pathologies can be associated with a total loss of corneal epithelial stem cells (i.e. Limbal Stem Cell Deficiency - LSCD), which leads to cornea invasion by the conjunctiva and a subsequent opacification. When LSCD is total and bilateral, both eyes are affected leading to full blindness and a poor quality of life, with a paradoxical photophobia that may be painful. Fewer than 100 patients bear this rare condition in France.

When patients suffer from total and bilateral LSCD, no treatment has been proven to provide clinical benefits: contralateral limbus is unavailable for autologous limbus graft or autologous limbal stem cells culture; allogeneic limbus graft requires immunosuppressive treatment leading to too important serious adverse effects compared to the expected benefit, and does not last long (< 2 years); and allogenic cornea transplantation is impossible since always rejected due to neovascularization.

A new way to treat these patients is to cultivate autologous corneal-like epithelium, and to graft it in order to restore transparency and to allow, if needed, a complementary corneal graft. Such an epithelium can be produced from autologous jugal mucosa cells. Epithelial jugal mucosa sheets transplantation has been assessed in a phase I/II clinical trial on 26 patients which showed that it is well-tolerated and effective but the culture technology used in this clinical trial is no longer available. A new enzymatic detachment process has been developed by the Hospices Civils de Lyon. Proof of concept was obtained from both in vitro and ex vivo studies: detachment with Collagenase at 0.5 mg/mL doesn't damage basement membrane proteins, so collagenase 0.5mg/mL-detached FEMJA were found to adhere, continue to ensure renewal of the differentiated epithelium 15 days after grafting onto an ex vivo porcine de-epitheliazed stroma model.

Considering these results, we aim to perform a clinical trial in order to evaluate tolerance and efficacy of the autologous jugal mucosa cell sheet (Feuillets Epithliaux de Muqueuse Jugale Autologue - FEMJA) cultured with this innovative process.

Details
Condition Total Bilateral Limbal Cell Deficiency
Treatment FEMJA transplatation
Clinical Study IdentifierNCT03949881
SponsorHospices Civils de Lyon
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Total Bilateral Limbal Cell Deficiency?
Do you have any of these conditions: Do you have Total Bilateral Limbal Cell Deficiency??
Do you have any of these conditions: Do you have Total Bilateral Limbal Cell Deficiency??
Do you have any of these conditions: Do you have Total Bilateral Limbal Cell Deficiency??
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 parameters: Erythrocyte Sedimentation Rate (ERS), 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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