Cultured Autologous Oral Mucosa Epithelial sheet for the Treatment of Bilateral Limbal Stem Cell Deficiency - FEMJA for « Feuillet Epithélial de Muqueuse Jugale Autologue »

Phase 1

• Conditions: Bilateral Limbal Stem Cell Deficiency; MedDRA version: 20.1Level: PTClassification code 10072138Term: Limbal stem cell deficiencySystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-003215-63-FR
• Lead Sponsor: Hospices Civils de Lyon - Direction de la Recherche Clinique et de l'Innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-27
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified