Cultured Human Corneal Endothelial Cell Injection for Endothelial Graft Failure After DSAEK.

Abstract

Endothelial graft failure after Descemet stripping automated endothelial keratoplasty (DSAEK) is a clinically relevant problem, and the current standard treatment is repeat keratoplasty, which carries risks of surgery-related complications and depends on donor availability. Cultured human corneal endothelial cell (HCEC) therapy injection represents a potentially regenerative alternative; however, safety and outcomes for failed DSAEK grafts have not been reported. To evaluate clinical outcomes of cultured HCEC therapy in eyes with endothelial graft failure after prior DSAEK. This prospective case series included 4 consecutive eyes with DSAEK graft failure treated with cultured HCEC therapy at Tokyo Dental College Ichikawa General Hospital in 2025. Intracameral injection of cultured HCEC therapy for endothelial dysfunction after DSAEK. Best-corrected visual acuity (BCVA, in logMAR [Snellen equivalent]), central corneal thickness (CCT), endothelial cell density (ECD), and intraocular pressure (IOP). A total of 4 eyes from 4 patients (mean [SD] age, 68.8 [9.3] years; 3 male [75%]) were included in this study. Mean (SD) BCVA improved from 1.93 (0.59) (Snellen, 20/1700) preoperatively to 0.46 (0.64) (Snellen, 20/60) at 3 months, with a mean change of -1.46 logMAR (15 Snellen lines; 95 CI, -1.87 to -1.05). Mean (SD) CCT changed from 900 (152) µm preoperatively to 641 (72) µm at 3 months with mean (SD) changes of -260 (73) µm (95% CI, -483 to -36 µm). Mean (SD) ECD could not be measured preoperatively because of severe corneal edema and was 1480 (989) cells/mm2 at 1 month and 2150 (723) cells/mm2 at 3 months. Mean (SD) IOP changed from 10 (2.1) mm Hg preoperatively to 13 (5.2) mm Hg at 3 months, with a mean (SD) change of +3.5 (2.1) mm Hg (95% CI, -7.6 to 14.6 mm Hg). Cystoid macular edema was observed in 2 eyes and was managed with topical diclofenac and sub-Tenon injections of triamcinolone acetonide. No other intraoperative and postoperative complications, including IOP elevation, infection, or graft detachment, were observed. Although limited to 4 eyes without controls, these findings suggest that cultured HCECs transplantation may be a feasible option for eyes with DSAEK graft failure. Confirmation in larger, controlled studies with longer follow-up is warranted.