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.

From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU / Pellegrini, Graziella; Lambiase, Alessandro; Macaluso, Claudio; Pocobelli, Augusto; Deng, Sophie; Cavallini, Gian Maria; Esteki, Roza; Rama, Paolo. - In: REGENERATIVE MEDICINE. - ISSN 1746-0751. - 11:4(2016), pp. 407-420. [10.2217/rme-2015-0051]

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

Macaluso, Claudio;
2016-01-01

Abstract

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.
2016
From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU / Pellegrini, Graziella; Lambiase, Alessandro; Macaluso, Claudio; Pocobelli, Augusto; Deng, Sophie; Cavallini, Gian Maria; Esteki, Roza; Rama, Paolo. - In: REGENERATIVE MEDICINE. - ISSN 1746-0751. - 11:4(2016), pp. 407-420. [10.2217/rme-2015-0051]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2840898
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