Long-term Corneal Rejuvenation after Transplantation of Cultured Human Corneal Endothelial Cells

Abstract

Purpose: To investigate the long-term efficacy of cultured human corneal endothelial cell (CEC) transplantation with ρ-associated protein kinase (ROCK) inhibitor for the treatment of corneal endothelial failure.

Design: Prospective observational study.

Participants: Sixty-five patients with corneal endothelial failure were treated via cell therapy using cultured allogeneic human CECs (0.2 - 1.0 × 10⁶ cells) supplemented with a ROCK inhibitor injected into the anterior chamber of the eye who were followed up for up to 10 years after surgery.

Methods: At 24 weeks and 1 to 10 years after surgery, corneal transparency, CEC density, central corneal thickness, and best-corrected visual acuity on a Landolt C eye chart were recorded. The Kaplan-Meier method was used to estimate the postoperative probability for restoration and persistence of corneal transparency.

Main outcome measures: The primary outcome was corneal restoration and transparency after surgery. Secondary outcomes were CEC density exceeding 500 and 1000 cells/mm², corneal thickness < 630 μm, and an improvement in best-corrected visual acuity (BCVA) equivalent to a decrease of at least 0.2 in logarithm of the minimal angle of resolution at 24 weeks and 5 years after surgery.

Results: For the primary outcome, the overall success in maintaining corneal transparency at 24 weeks, 5 years, and 10 years after surgery was 98.5% (95% confidence interval [CI], 89.6%-99.8%), 93.0% (95% CI, 82.4%-97.3%), and 83.7% (95% CI, 54.4%-95.0%), respectively. A CEC density of more than 1000 cells/mm² was achieved in 79.6% (95% CI, 65.7%-89.8%), corneal thickness < 630 μm was achieved in 85.4% (95% CI, 72.2%-93.9%), and BCVA improvement was achieved in 85.7% (95% CI, 72.8%-94.1%) at 5 years after surgery. No severe adverse reactions occurred.

Conclusions: Cultured human CEC transplantation provided sustained clinical improvement and demonstrated a favorable long-term safety profile in patients with corneal endothelial failure.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Keywords: Cell injection; Cell transplantation; Corneal endothelial cell; Corneal endothelial failure; ρ-associated protein kinase inhibitor.