title: Cell-based therapy technology classifications and translational challenges.
abstract: Cell therapies offer the promise of treating and altering the course of diseases which cannot be addressed adequately by existing pharmaceuticals. Cell therapies are a diverse group across cell types and therapeutic indications and have been an active area of research for many years but are now strongly emerging through translation and towards successful commercial development and patient access. In this article, we present a description of a classification of cell therapies on the basis of their underlying technologies rather than the more commonly used classification by cell type because the regulatory path and manufacturing solutions are often similar within a technology area due to the nature of the methods used. We analyse the progress of new cell therapies towards clinical translation, examine how they are addressing the clinical, regulatory, manufacturing and reimbursement requirements, describe some of the remaining challenges and provide perspectives on how the field may progress for the future.
authors.affiliation: Cell Therapy Catapult, Guy's Hospital, London SE1 9RT, UK natalie.mount@ct.catapult.org.uk.
authors.forename: Natalie M
authors.initials: NM
authors.lastname: Mount
authors.affiliation: Cell Therapy Catapult, Guy's Hospital, London SE1 9RT, UK.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Ward
authors.affiliation: Cell Therapy Catapult, Guy's Hospital, London SE1 9RT, UK.
authors.forename: Panos
authors.initials: P
authors.lastname: Kefalas
authors.affiliation: Cell Therapy Catapult, Guy's Hospital, London SE1 9RT, UK Division of Biotechnology, IFM, Linköping University, Linköping 581 83, Sweden.
authors.forename: Johan
authors.initials: J
authors.lastname: Hyllner
mesh_terms: D000818:Animals; D001709:Biotechnology / Q000639:trends; D002461:Cell Line, Transformed; D064987:Cell- and Tissue-Based Therapy / Q000145:classification* / Q000191:economics / Q000639:trends; D000067470:Cellular Reprogramming Techniques; D005822:Genetic Vectors; D006801:Humans; D017393:RNA Editing; D023822:Tissue Engineering; D057170:Translational Research, Biomedical / Q000639:trends
keywords: cell therapy; clinical trial; manufacturing; regulation; reimbursement; translation