International Stem Cell Banking Initiative, 2 High Street, Barley, Hertfordshire SG8 8HZ, UK.
Centre for Stem Cell Biology, Department of Biomedical Science, The University of Sheffield, Sheffield, S10 2TN, UK.
Regen Med. 2019 Mar;14(3):243-255. doi: 10.2217/rme-2019-0001. Epub 2019 Apr 2.
Human stem cells have the potential to transform medicine. However, hurdles remain to ensure that manufacturing processes produce safe and effective products. A thorough understanding of the biological processes occurring during manufacture is fundamental to assuring these qualities and thus, their acceptability to regulators and clinicians. Leaders in both human pluripotent and somatic stem cells, were brought together with experts in clinical translation, biomanufacturing and regulation, to discuss key issues in assuring appropriate manufacturing conditions for delivery of effective and safe products from these cell types. This report summarizes the key issues discussed and records consensus reached by delegates and emphasizes the need for accurate language and nomenclature in the scientific discourse around stem cells.
人类干细胞具有改变医学的潜力。然而，仍存在一些障碍需要克服，以确保制造过程能够生产出安全有效的产品。彻底了解制造过程中发生的生物学过程对于确保这些质量，从而确保监管机构和临床医生能够接受这些产品，是至关重要的。召集了人类多能干细胞和体细胞干细胞领域的领导者，以及临床转化、生物制造和监管方面的专家，共同讨论确保这些细胞类型有效和安全产品交付的合适制造条件的关键问题。本报告总结了讨论的关键问题，并记录了代表们达成的共识，强调了在干细胞科学论述中使用准确语言和术语的必要性。
