Mount Natalie M, Ward Stephen J, Kefalas Panos, Hyllner Johan
Cell Therapy Catapult, Guy's Hospital, London SE1 9RT, UK
Cell Therapy Catapult, Guy's Hospital, London SE1 9RT, UK.
Philos Trans R Soc Lond B Biol Sci. 2015 Oct 19;370(1680):20150017. doi: 10.1098/rstb.2015.0017.
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.
细胞疗法有望治疗并改变现有药物无法充分应对的疾病进程。细胞疗法涵盖多种细胞类型和治疗适应症,多年来一直是活跃的研究领域,但目前正通过转化研究强势崛起,朝着成功的商业开发和患者可及性迈进。在本文中,我们基于细胞疗法的基础技术而非更常用的按细胞类型分类来描述其分类情况,因为由于所使用方法的性质,同一技术领域内的监管途径和生产解决方案通常相似。我们分析了新型细胞疗法向临床转化的进展,研究它们如何满足临床、监管、生产和报销要求,描述了一些尚存的挑战,并就该领域未来如何发展提供了观点。