European regulation for therapeutic use of stem cells

Issue title: Selected papers from the 6th China–France International Symposium “Stem Cells and Regenerative Medicine” and the first meeting of the France–China International CNRS Network (GDRI) CeSMeR, Nancy, 10–13 July 2016

Guest editors: J.-F. Stoltz, J. Magdalou and D. Bensoussan

Article type: Research Article

Authors: Ferry, Nicolas

Affiliations: Département de thérapie cellulaire, Hôpital Saint Louis, 1 Avenue Claude Vellefaux, 75010 Paris, France. E-mail: [email protected]

Abstract: The regulation for the use of stem cells has evolved during the past decade with the aim of ensuring a high standard of quality and safety for human derived products throughout Europe to comply with the provision of the Lisbon treaty. To this end, new regulations have been issued and the regulatory status of stem cells has been revised. Indeed, stem cells used for therapeutic purposes can now be classified as a cell preparation, or as advanced therapy medicinal products depending on the clinical indication and on the procedure of cell preparation. Furthermore, exemptions to the European regulation are applicable for stem cells prepared and used within the hospital. The aim of this review is to give the non-specialized reader a broad overview of this particular regulatory landscape.

Keywords: European regulation, Advanced Therapy Medicinal Products (ATMP), somatic cell therapy, tissue engineering

DOI: 10.3233/BME-171619

Journal: Bio-Medical Materials and Engineering, vol. 28, no. s1, pp. S3-S7, 2017