自體培養角膜邊緣上皮細胞片移植治療角膜幹細胞缺陷患者的臨床試驗

Ophthalmology Volume 130, Number 6, June 2023

中文摘要

本研究旨在評估自體培養的角膜上皮細胞片在單側角膜幹細胞缺陷（LSCD）患者中的療效和安全性。該研究納入了十名單側LSCD患者，進行自體細胞片移植後的兩年追蹤。這些細胞片是在符合良好製造規範（GMP）的設施中製備的，並遵循良好臨床實踐準則。主要終點是角膜上皮重建率，該終點在手術後一年進行評估。結果顯示，在移植後一年，60%的眼睛成功進行了角膜上皮重建，這一成功率顯著高於同種角膜移植(allogeneic limbal transplantation)的成功率。包括視力改善和生活質量在內的次要終點也顯示出積極的結果。該研究結論認為自體培養的角膜上皮細胞片是一種安全有效的LSCD治療方法。這些發現支持在眼科再生醫學中應用這種方法。

English Abstract

This study aimed to evaluate the efficacy and safety of autologous cultivated limbal epithelial cell sheets in patients with unilateral limbal stem cell deficiency (LSCD). The study included ten patients with unilateral LSCD who were followed for two years after the transplantation of autologous cell sheets. The cell sheets were fabricated in a Good Manufacturing Practice (GMP)-compliant facility and adhered to Good Clinical Practice guidelines. The primary endpoint was the corneal epithelial reconstruction rate, which was evaluated one year postoperatively. The results showed that corneal epithelial reconstruction was successful in 60% of eyes one year after the transplantation, which was significantly higher than the success rate achieved by allogeneic limbal transplantation. The secondary endpoints, including visual acuity improvement and quality of life, also showed positive outcomes. The study concluded that autologous cultivated limbal epithelial cell sheets are a safe and effective treatment for LSCD. The findings support the use of this approach in ocular regenerative medicine.