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/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. 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.