Bilateral Limbal Stem Cell Deficiency MedDRA version: 20.1 Level: PT Classification code 10072138 Term: Limbal stem cell deficiency System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Feuillet Epithélial de Muqueuse Jugale Autologue
Product Code: FEMJA
Pharmaceutical Form: Living tissue equivalent
Current Sponsor code: FEMJA
Other descriptive name: Autologous oral muc
Sponsors
Hospices Civils de Lyon - Direction de la Recherche Clinique et de l'Innovation
Eligibility
Sex/Gender
All
Inclusion 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 (=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 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 - Oral mucosa tumor or infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of visual acuity at 24 months after jugal mucosa epithelial sheet (FEMJA) transplantation on the grafted eye (one eye treated per patient).;Secondary Objective: - Feasibility of the jugal mucosa epithelial sheet graft; - Tolerance of the jugal mucosa epithelial sheet; - Efficacy of the jugal mucosa epithelial sheet in terms of quality of the reconstructed epithelium (physical signs), neovascularization, and symptoms (functional signs); - Graft rejection for patients with secondary corneal graft; - Relation between biological FEMJA characteristics (extraction yield, percentage of proliferative epithelial cells) and change in visual acuity. ;Primary end point(s): Number of patients with any improvement in visual acuity, measured at baseline (i.e. the day of jugal mucosa biopsy; preoperative status) and 24 months after jugal mucosa epithelial cell sheet (FEMJA) transplantation, according to the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. ETDRS LogMAR tests allow measurement of very low visual acuity. ;Timepoint(s) of evaluation of this end point: 24 months after jugal mucosa epithelial cell sheet (FEMJA) transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 / Related to feasibility: Success rates of the culture, of the detachment, and of the FEMJA graft itself: obtaining at least one sheet per patient, and transplantation of FEMJA without perforating it. 2/ Related to tolerance/safety: Adverse events related to the procedure; especially expected adverse events: inflammation, infection, and perforation. 3/ Related to efficacy: - Number of patients with at least one point of improvement of the following items at 6 months, 12 months, 18 months and 24 months: * Quality of reconstructed epithelium, i.e. physical signs measured by the ophthalmologist using a slit lamp, in terms of: persistant epithelial defect; superficial punctate epithelial keratitis; and conjunctival epithelium on cornea; * Neovascularization, in terms of number of vascular pediculus near the limbus and their activity; * Symptoms, i.e. functional signs measured with Likert scales by self-reporting from the patient, in terms of: photophobia, eye dryness, and pain. - Number of patients with secondary corneal graft and presenting graft rejection, defined by intraocular pression (= 22mmHg) and corneal topography (significant increase in the thickness of the stroma of the cornea compared to the measured value just after the graft). 4/ Biological endpoints: FEMJA characteristics (extraction yield, percentage of proliferative epithelial cells) will be compared according to the clinical response for changes in visual acuity at M24. ;Timepoint(s) of evaluation of this end point: 6 months, 12 months, 18 months and 24 months months after jugal mucosa epithelial cell sheet (FEMJA) transplantation | — |
Countries
France
Contacts
Public ContactCatherine CERESER
Hospices Civils de Lyon - Direction de la Recherche Clinique et de l'Innovation
Outcome results
None listed