EUCTR2019-003215-63-FR
Active, not recruiting
Phase 1
Cultured Autologous Oral Mucosa Epithelial sheet for the Treatment of Bilateral Limbal Stem Cell Deficiency - FEMJA for « Feuillet Epithélial de Muqueuse Jugale Autologue » - FEMJA
Hospices Civils de Lyon - Direction de la Recherche Clinique et de l'Innovation0 sites40 target enrollmentNovember 27, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hospices Civils de Lyon - Direction de la Recherche Clinique et de l'Innovation
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
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
- •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
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)
Outcomes
Primary Outcomes
Not specified
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