RAFT: Corneal Stem Cells - First in Man Safety Study

TAP Biosystems and UCL Institute of Ophthalmology are developing a novel, patented technology (RAFT) that enables 3D tissue equivalents to be manufactured from collagen simply and reproducibly. The RAFT process creates tissue-like architectures that we are using to develop a corneal therapy - with embossed surface topography to replicate the in vivo stem cell niche - to support ocular surface regeneration. Results are very promising; we can reproducibly make multilayered ocular epithelia with morphology and protein markers very like the normal human cornea. We have advanced preclinical work, defining safety testing, regulatory pathway and the basis for QC assays. Our aim in this project is to complete preclinical testing, obtain regulatory and ethical approval, then manufacture the therapy in GMP conditions and perform a small first in man safety study at Moorfields Eye Hospital under Specials Hospitals Exemption arrangements. The data from this study would enable us to progress towards phase I/II clinical trials.