💬In plain words
What the trial is, and whether it could suit you
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 transp
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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