SPECIAL ARTICLE   

Gazzetta Medica Italiana Archivio per le Scienze Mediche 2018 May;177(5):229-36

DOI: 10.23736/S0393-3660.17.03547-1

Copyright © 2017 EDIZIONI MINERVA MEDICA

language: Italian

Analysis of the european legal regulation on advanced therapy products: a guide to possible clinical applications of ascs

Elisa BELLINI ✉, Edoardo RAPOSIO

Department of Medicine and Surgery, Plastic Surgery Clinic, School of Specialization in Plastic, Reconstructive and Aesthetic Surgery, University Hospital of Parma, Parma, Italy

Mesenchymal stem cells derived from adipose tissue are cells with high differentiation capacity, high bioavailability and very low morbidity of the collection site, making these cells ideal for regenerative medicine therapies. The high interest of recent years towards this promising resource has made European legislative adjustment indispensable. Such products must be subject to specific legal rules on their production, distribution and use with the primary purpose of protecting public health. The purpose of this study was to describe and analyze existing European legislation to provide guidance on the correct definitions and isolation or manipulation techniques allowed for all practitioners involved in regenerative medicine.

KEY WORDS: Adult stem cells - Legislation - Europe