Autologous Cultured Corneal Epithelium Transplant to Treat Limbal Stem Cell Deficiency in One or Both Eyes

What this Trial Is About

Researchers are evaluating the use of Autologous Cultured Corneal Epithelium CECA for treating corneal lesions caused by limbal stem cell deficiency, a condition affecting the eyes surface. This is the first clinical trial using a CECA product made at the LOEX laboratory. The study is a phase III trial designed to assess the safety and effectiveness of this graft in patients suffering from this condition. The trial includes participants of all genders, with plans to include five minors. The treatment involves surgical transplantation of the CECA graft, which is cultured corneal epithelium aimed at repairing damaged tissue caused by limbal stem cell deficiency. This procedure is the main intervention and is designed to restore the corneal surface by transplanting the reconstructed tissue to the affected eye. The trial does not involve additional treatment groups or placebo comparisons. Participants will be monitored for one year after the transplantation, with evaluations including anatomic assessments of the cornea, measurements of best corrected visual acuity, pain levels, and quality of life. These assessments help researchers understand the grafts impact on eye health and patient well-being. The study is sponsored by CHU de Quebec-Universite Laval and began in December 2012, with an estimated end date in December 2027.

Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency