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

Launched by HOSPICES CIVILS DE LYON · May 13, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for people suffering from a serious eye condition called total bilateral limbal stem cell deficiency (LSCD). This condition can result from severe eye injuries, leading to vision loss and an inability to see clearly. The trial is testing a method that uses cells from the inside of the cheek (jugal mucosa) to create a new layer of cells that can be transplanted onto the eye, potentially restoring some vision and improving quality of life for those affected.

To be eligible for the trial, participants must be at least 18 years old and have total bilateral LSCD caused by conditions like chemical or thermal burns. They should also have significant vision loss. Participants will undergo the new treatment and be monitored for how well their bodies tolerate it and whether it improves their eyesight. It is important to know that certain health conditions, like active infections or specific eye problems, may exclude individuals from participating in the study. This trial represents a hopeful step forward for patients with this rare and challenging condition.

Gender

ALL

Eligibility 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