Cultured Autologous Oral Mucosa Epithelial Sheet for the Treatment of Bilateral Limbal Stem Cell Deficiency

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 13, 2020

Primary Completion Date

May 13, 2029

Study Completion Date

May 13, 2029

Conditions
Total Bilateral Limbal Cell Deficiency
Interventions
BIOLOGICAL

FEMJA transplatation

The cultivated oral mucosal epithelium will be directly grafted onto the corneal stroma. The sheet is grafted without suture onto the exposed stromal bed after removal of the conjunctiva and fibrosis from the cornea. The grafted corneal surface is then covered with a soft permanent contact lens for protection during healing (between 3 to 15 days, according to tolerance) If the stroma appears opaque because of deep stromal scars a corneal allograft will be performed 12 months after FEMJA transplantation.

Trial Locations (1)

69003

RECRUITING

Ophthalmology department, Edouard Herriot hospital, Hospices Civils de Lyon, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT03949881 - Cultured Autologous Oral Mucosa Epithelial Sheet for the Treatment of Bilateral Limbal Stem Cell Deficiency | Biotech Hunter | Biotech Hunter