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 个研究点目标入组 40 人开始时间: 2019年11月27日最近更新: 2020年3月18日

试验速览

暂无简介。

•- 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

•- 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

发起方

Hospices Civils de Lyon - Direction de la Recherche Clinique et de l'Innovation