In 1997, the human corneal epithelium was reconstructed in vitro and transplanted on patients. Later, it became a routine treatment, before regulations considered advanced therapy medicinal products and drugs on the same lines. Manufacturing, before and after good manufacturing practice setting, was established in different facilities and the clinical application in several hospitals. Advanced therapy medicinal products, including stem cells, are unique products with different challenges than other drugs: some uncertainties, in addition to benefit, cannot be avoided. This review will focus on all recent developments in the stem cell-based corneal therapy.
Keywords: ATMP commercialization; adult corneal stem cells; artificial organs; cell therapy; culture/differentiation of stem cells (niche); ophthalmology; regenerative medicine; tissue engineering; translational studies; transplantation.