title: European regulation for therapeutic use of stem cells.
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.
authors.affiliation: Département de thérapie cellulaire, Hôpital Saint Louis, 1 Avenue Claude Vellefaux, 75010 Paris, France. E-mail: Nferry57@gmail.com.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Ferry
mesh_terms: D064987:Cell- and Tissue-Based Therapy / Q000592:standards; D002986:Clinical Trials as Topic; D005060:Europe; D005062:European Union; D006801:Humans; D007883:Legislation, Medical / Q000592:standards; D011786:Quality Control; D033581:Stem Cell Transplantation / Q000331:legislation & jurisprudence* / Q000592:standards; D013234:Stem Cells / Q000145:classification / Q000166:cytology; D023822:Tissue Engineering / Q000592:standards
keywords: Advanced Therapy Medicinal Products (ATMP); European regulation; somatic cell therapy; tissue engineering