From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU

@inproceedings{Pellegrini2016FromDT,
  title={From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU},
  author={G. Calliumi Pellegrini and Alessandro Lambiase and Claudio Macaluso and Augusto Pocobelli and Sophie Xiaohui Deng Deng and Gian Maria Cavallini and Roza Esteki and Pathapati Rama},
  booktitle={Regenerative medicine},
  year={2016}
}
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… CONTINUE READING

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