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

Graziella Pellegrini, Alessandro Lambiase, Claudio Macaluso, Augusto Pocobelli, Sophie Deng, Gian Maria Cavallini, Roza Esteki, Paolo Rama

Research output: Contribution to journalReview articlepeer-review

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.

Original languageEnglish
Pages (from-to)407-420
Number of pages14
JournalRegenerative Medicine
Volume11
Issue number4
DOIs
Publication statusPublished - Jun 1 2016

Keywords

  • adult corneal stem cells
  • artificial organs
  • ATMP commercialization
  • cell therapy
  • culture/differentiation of stem cells (niche)
  • ophthalmology
  • regenerative medicine
  • tissue engineering
  • translational studies
  • transplantation

ASJC Scopus subject areas

  • Biomedical Engineering
  • Embryology

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