Five-Year Follow-up of First Eleven Cases Undergoing Injection of Cultured Corneal Endothelial Cells for Corneal Endothelial Failure

Abstract Purpose To report the safety and efficacy of a novel cell-injection therapy using cultured human corneal endothelial cells (hCECs) for endothelial failure conditions via the report of the long-term clinical data of 5-years postoperative in a 'first-in-man' clinical trial group. Design Prospective observational study. Participants This study involved 11 eyes of 11 patients with pseudophakic endothelial failure conditions who underwent hCEC-injection therapy between December 2013 and December 2014. Methods All patients underwent follow-up examinations at 1-, 4-, 12-, and 24-weeks and 1-, 2-, 3-, 4-, and 5-years postoperative. Specific corneal endothelial cell parameters [i.e., corneal endothelial cell density (ECD), coefficient of variation of area, and percentage of hexagonal cells] and central corneal thickness, best-corrected visual acuity (BCVA) on a Landolt C eye chart, and intraocular pressure were recorded. Main Outcome Measures The primary outcome was the change of central ECD post cell-injection therapy, and the secondary outcome was corneal thickness, BCVA, and intraocular pressure during the 5-year-postoperative follow-up periods. Results At 5-years postoperative, normal corneal endothelial function was restored in 10 of the 11 eyes, the mean central corneal ECD was 1,257 ± 467 cells/mm2 (± SD) (range, 601 to 2,067 cells/mm2), BCVA was significantly improved in 10 treated eyes, the mean logMAR VA had changed to 0.046 from that of 0.876 at prior to surgery, and no major adverse reactions directly related to the ‘hCEC-injection therapy’ were observed. Conclusions The findings in this study confirmed the safety and efficacy of cultured hCEC-injection therapy for up to 5-years postoperative.