Treatment of Total Bilateral Limbal Stem Cell Deficiency Using Cultured Autologous Oral Mucosa Epithelial Sheets FEMJA

What this Trial Is About

Researchers are evaluating a new treatment for total bilateral limbal stem cell deficiency LSCD, a rare eye condition caused by severe burns or other ocular diseases that lead to blindness and poor quality of life. This condition results in loss of corneal epithelial stem cells, causing conjunctival invasion and corneal clouding. Currently, no proven effective treatments exist for total bilateral LSCD, and existing options have significant limitations and risks. The study involves transplantation of cultivated autologous oral mucosal epithelial sheets FEMJA directly onto the corneal stroma without sutures. The sheets adhere strongly and rapidly, protected by a soft contact lens during healing for 3 to 15 days. If the corneal stroma remains opaque due to scars, a complementary corneal graft may be performed 12 months after the FEMJA transplantation. This trial builds on earlier phase III studies that showed safety and effectiveness using a different culture method. Participants will have their oral mucosa cells cultured into epithelial sheets using a new enzymatic detachment process and grafted onto the eye. Researchers will monitor visual acuity improvement, transplant success, adverse events, and changes in eye signs and symptoms over 24 months. Safety assessments include monitoring for corneal graft rejection and correlations between biological characteristics of the transplanted sheets and visual outcomes. The total follow-up period is 24 months after transplantation.

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