Advanced 4D Printing Technologies in Corneal Regeneration: A Pathway to Restored Vision

Corneal blindness is the 3rd leading cause of blindness globally, affecting >11.7mi people. Although the cornea is the most transplanted tissue, only 1-in-70 patients in need receive a cornea due to a severe shortage of donor tissue.3D bioprinting offers an attractive solution. However, existing technology cannot mimic the complexity of cornea tissue, which is necessary to reproduce its optomechanical & biological functionality.The KeratOPrinter project thus, proposes a highly ambitious approach to develop a 4D bioprinting suite that can deliver a fully functional, biocompatible, full-thickness native-like human cornea. The consortium combines world-class partners to provide:a) An innovative & scalable cell source with high cell viability & native-like functionality in vivo for the different cell types in the cornea; b) Several multi-material bioink formulations which can reproduce the native-environment heterogeneity & extracellular matrix to deliver the optical, mechanical & biological functionality; c) Single-cell bioprinting resolution with µm accuracy & in-process monitoring for clinical-level quality control at viable printing speeds; d) Clinical handling technology for transportation, logistics & surgical implementation, supported by complementary implementation of multiple bioprinting technologies; e) GMP-compliant cell manufacturing and bioprinting technologies supported by in vivo & GLP studies for fast translation to the clinical environment; f) Early regulatory engagement augmented by a thorough regulatory and ethical analysis culminating in a comprehensive regulatory pathway to support future commercialisation and g) A dedicated community of researchers, clinicians, healthcare providers, regulatory and standardisation bodies, patient groups, technology developers, & industry to translate project results into targeted outcomes & long-term impacts.Ultimately, KeratOPrinter aims to enable millions of people to receive vision-saving therapy by 2035.