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Graziella Pellegrini; Hurdles and advantages in an example of regenerative medicine. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3476.
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Recent breakthroughs in regenerative medicine have generated enthusiasm and many efforts to explore new therapeutic potentials of both somatic and pluripotent stem cells. About 30 years passed since a discovery of a method of producing a great number of human epidermal keratinocytes by cultivation from a small skin biopsy. Many possibilities are now envisaged for therapeutic application of different cultured cell types. The purpose of this work is to understand whether regenerative medicine will offer, in the near future, new therapies and an unimpeded distribution by academies and by the new pharmaceutical industry throughout the world.
An extensive and experimental work was done to test whether a stem cell therapy can be classified under the European regularory framework, designed for chemical manufacturing in the last century. Reclassification of biological parameters in a EU GMP environment has been presented.
Ocular burns cause depletion of limbal stem cells, which leads to corneal opacification and visual loss. Most of available treatments are palliative and focused on the relief of the devastating clinical picture. Several studies focused on recent developments in cell-based therapy of limbal stem cell deficiency. After 15 years follow-up, all findings provide data for improvement and support aimed to a standardization of the cure for this disabling disease.
Living cell-based products present many challenges in today's highly regulated healthcare environment; however, analysis of all experimental conditions and deep knowledge of the process can provide strong support to translation of biology in a regulatory environment.
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