title: Risk of tumorigenicity in mesenchymal stromal cell-based therapies--bridging scientific observations and regulatory viewpoints.
abstract: In the past decade, the therapeutic value of mesenchymal stromal cells (MSCs) has been studied in various indications, thereby taking advantage of their immunosuppressive properties. Easy procurement from bone marrow, adipose tissue or other sources and conventional in vitro expansion culture have made their clinical use attractive. Bridging the gap between current scientific knowledge and regulatory prospects on the transformation potential and possible tumorigenicity of MSCs, the Cell Products Working Party and the Committee for Advanced Therapies organized a meeting with leading European experts in the field of MSCs. This meeting elucidated the risk of potential tumorigenicity related to MSC-based therapies from two angles: the scientific perspective and the regulatory point of view. The conclusions of this meeting, including the current regulatory thinking on quality, nonclinical and clinical aspects for MSCs, are presented in this review, leading to a clearer way forward for the development of such products.
authors.affiliation: Cell Products Working Party, European Medicines Agency, London, UK.
authors.forename: Lisbeth
authors.initials: L
authors.lastname: Barkholt
authors.forename: Egbert
authors.initials: E
authors.lastname: Flory
authors.forename: Veronika
authors.initials: V
authors.lastname: Jekerle
authors.forename: Sophie
authors.initials: S
authors.lastname: Lucas-Samuel
authors.forename: Peter
authors.initials: P
authors.lastname: Ahnert
authors.forename: Louise
authors.initials: L
authors.lastname: Bisset
authors.forename: Dirk
authors.initials: D
authors.lastname: Büscher
authors.forename: Willem
authors.initials: W
authors.lastname: Fibbe
authors.forename: Arnaud
authors.initials: A
authors.lastname: Foussat
authors.forename: Marcel
authors.initials: M
authors.lastname: Kwa
authors.forename: Olivier
authors.initials: O
authors.lastname: Lantz
authors.forename: Romaldas
authors.initials: R
authors.lastname: Mačiulaitis
authors.forename: Tiina
authors.initials: T
authors.lastname: Palomäki
authors.forename: Christian K
authors.initials: CK
authors.lastname: Schneider
authors.forename: Luc
authors.initials: L
authors.lastname: Sensebé
authors.forename: Gérard
authors.initials: G
authors.lastname: Tachdjian
authors.forename: Karin
authors.initials: K
authors.lastname: Tarte
authors.forename: Lucie
authors.initials: L
authors.lastname: Tosca
authors.forename: Paula
authors.initials: P
authors.lastname: Salmikangas
mesh_terms: D000273:Adipose Tissue / Q000166:cytology; D001854:Bone Marrow Cells / Q000166:cytology; D063646:Carcinogenesis; D018929:Cell Culture Techniques; D002454:Cell Differentiation / Q000235:genetics; D049109:Cell Proliferation; D006801:Humans; D045164:Mesenchymal Stem Cell Transplantation / Q000009:adverse effects*; D059630:Mesenchymal Stem Cells / Q000166:cytology* / Q000378:metabolism