Laurencin Cato T, McClinton Aneesah
Connecticut Convergence Institute for Translation in Regenerative Engineering, UConn Health, Farmington, CT 06030, USA.
Raymond and Beverly Sackler Center for Biological, Physical and Engineering Sciences, UConn Health, Farmington, CT 06030, USA.
Regen Eng Transl Med. 2020 Mar;6(1):78-89. doi: 10.1007/s40883-020-00147-1. Epub 2020 Feb 19.
With the emergence of cell-based therapies as viable treatment options readily accessible to patients, the scientific community and public have raised concerns regarding consumer accessibility and regulation enforcement. Opposing viewpoints regarding regulation have emerged, and efforts to maintain the balance between promoting scientific innovation and ensuring public safety has proved challenging. To further complicate matters, there is contradictory information regarding the clinical safety and efficacy of cell-based treatments. Herein, we outline the FDA's regulatory framework for cell-based therapies and describe what we term the cutting edge, bleeding edge, and off the edge interventions. We conclude with a new classification system for regenerative cell-based therapies intended to further aid in delineating between the clinically and scientifically sound therapies to those that compel further scientific investigation.
随着基于细胞的疗法成为患者可轻易获得的可行治疗选择，科学界和公众对消费者的可及性以及监管执法提出了担忧。关于监管出现了对立的观点，而在促进科学创新与确保公众安全之间维持平衡的努力已证明具有挑战性。更复杂的是，关于基于细胞的治疗的临床安全性和有效性存在相互矛盾的信息。在此，我们概述了美国食品药品监督管理局（FDA）针对基于细胞的疗法的监管框架，并描述了我们所称的前沿、前沿边缘和边缘之外的干预措施。我们最后提出了一种用于基于细胞的再生疗法的新分类系统，旨在进一步帮助区分临床上和科学上合理的疗法与那些需要进一步科学研究的疗法。
