Superiority of Mature Differentiated Cultured Human Corneal Endothelial Cell Injection Therapy for Corneal Endothelial Failure.

PURPOSE To investigate the safety and efficacy of cultured human corneal endothelial cell (hCEC)-injection therapy with mature differentiated (mature) cell subpopulations (SPs) for corneal endothelial failure (CEF). DESIGN Comparative, interventional case series. METHODS This study involved 18 eyes with CEF that underwent cultured hCEC-injection therapy, categorized into two groups: 1) 11 eyes administered a relatively lower proportion (0.1 to 76.3%) of mature cell SPs [Group 1 (Gr1)], and 2) 7 eyes administered a relatively higher proportion (>90%) of mature cell SPs [Group 2 (Gr2)]. From 1-week to 3-years postoperative, corneal endothelial cell (CEC) density (CECD), central corneal thickness (CCT), and best-corrected visual acuity (BCVA) were recorded, and the CEC parameter's 'spring constant' was calculated. The proportion of mature SPs was evaluated by fluorescence-activated cell sorting analysis based on cell-surface markers. RESULTS At 3-years postoperative, corneal restoration with improved BCVA was attained in 10 of the 11 Gr1 eyes and all Gr2 eyes, the median CECD in Gr2 (3,083 cells/mm2; range, 2,182-4,417 cells/mm2) was higher than that in Gr1 (1,349 cells/mm2; range, 746-2,104 cells/mm2) (P < 0.001), and the spring constant verified the superiority of the mature cultured hCECs. From 24-weeks through 3-years postoperative, the median percentage of CECD decrease was 3.2% in Gr2 and 23.6% in Gr1 (P < 0.005). CCT recovery was prompt and constant in Gr2, while diverse in Gr1. No adverse events were observed. CONCLUSION Our findings showed that mature cell SPs for hCEC-injection therapy provide rapid recovery of CCT, better CECD, and low CECD attrition over 3 years post surgery.