Next generation corneal implants as alternative to high risk donor transplantation

Abstract

AbstractWe have previously shown that recombinant human collagen (RHC)‐based hydrogels fabricated into cell‐free corneal implants are able to induce regeneration of the corneas of 10 patients in a Phase 1 clinical study. At four years post‐operative, all implants were stably integrated without the use of sustained immunosuppression. Corneal tissue and nerves were regenerated. For use in high risk corneal transplantation such as burns and cases of persistent, non‐infectious ulcers, we had reinforced the collagen implants with a second network of synthetic phosphorylcholine to form a hydogel comprising of interpenetratig networks of collagen‐phosphorylcholine (RHC‐MPC). In a pilot study within a hospital setting, in accordance to the Declaration of Helsinki, with ethical permission and informed consent, four patients were grafted with cell‐free RHC‐MPC implants after manual excision of the ulcerated areas. After six to 12 months post‐grafting, all implanted corneas had a stable epithelium and visual acuity improved 1‐2 lines compared to pre‐operative levels. Our pilot study shows RHC‐MPC implants are safe in patients and appeared to withstand the adverse microenvironment within the corneas with severe pathology and high risk of rejection.