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

Importance 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. Objective To evaluate clinical outcomes of cultured HCEC therapy in eyes with endothelial graft failure after prior DSAEK. Design, Setting, and Participants 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. Exposure Intracameral injection of cultured HCEC therapy for endothelial dysfunction after DSAEK. Main Outcomes and Measures Best-corrected visual acuity (BCVA, in logMAR Snellen equivalent), central corneal thickness (CCT), endothelial cell density (ECD), and intraocular pressure (IOP). Results 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/mm 2 at 1 month and 2150 (723) cells/mm 2 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. Conclusions and Relevance 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.