title: Quality Assured Characterization of Stem Cells for Safety in Banking for Clinical Application.
abstract: The promise of human pluripotent stem cells to serve as a scalable and renewable starting material for "off the shelf" therapeutic cell products to repair or replace cells and tissues damaged by disease or injury is unparalleled. Whether originating from embryos or the genetic manipulation of adult tissue-derived cells, this prospective impact dictates a comprehensive yet practicable standard of quality assured characterization, blending existing and bespoke standards and considerations. Here, we provide a guide to qualifying the suitability of this resource for human clinical application.
authors.affiliation: Censo Biotechnologies Ltd and Roslin Cell Sciences Ltd, Wallace Building, Roslin BioCentre, Midlothian, EH25 9PP, UK. Kevin.Bruce@roslincs.com.
authors.forename: Kevin W
authors.initials: KW
authors.lastname: Bruce
authors.affiliation: Scottish Blood Transfusion Service, 21 Ellen's Glen Rd, Edinburgh, EH17 7QT, UK.
authors.forename: John D M
authors.initials: JD
authors.lastname: Campbell
authors.affiliation: Censo Biotechnologies Ltd and Roslin Cell Sciences Ltd, Wallace Building, Roslin BioCentre, Midlothian, EH25 9PP, UK.|Centre for Clinical Brain Sciences, University of Edinburgh, Chancellors Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: De Sousa
mesh_terms: D000818:Animals; D018070:Biological Specimen Banks / Q000592:standards*; D006801:Humans; D039904:Pluripotent Stem Cells / Q000166:cytology*
keywords: Cell identity; Characterization; Pluripotent stem cell; Procurement; Quality assurance; Quality control; Safety; Stem cell banking