Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children's Research Hospital, Memphis, Tennessee.
Nimitt Consulting, Spicer, Minnesota.
Transplant Cell Ther. 2022 Dec;28(12):795-801. doi: 10.1016/j.jtct.2022.08.029. Epub 2022 Sep 2.
As the field of cellular and genetic therapies transitions from a scientific concept to a clinical reality, it has become evident that there are several conflicting or imprecise nomenclatures to describe these novel therapeutic products. The lack of uniformity and accuracy in the terminology often creates regulatory, educational, administrative, and billing quagmires. Standardization of the nomenclature for these therapeutic products is essential for creation of a harmonized regulatory and developmental framework, development of training paradigms and educational programs, equitable and rational decisions about accessibility, and consistency in the billing and coding structures used for reimbursement. Here we propose an updated framework as a foundation for categorizing these cell-based and genetically modified therapies.
随着细胞和基因治疗领域从科学概念向临床现实转变，显然有几种相互冲突或不精确的命名法来描述这些新型治疗产品。术语的缺乏统一性和准确性常常导致监管、教育、行政和计费方面的困境。这些治疗产品的命名法的标准化对于创建一个协调的监管和开发框架、培训模式和教育计划的发展、公平和合理的可及性决策以及用于报销的计费和编码结构的一致性是至关重要的。在这里，我们提出了一个更新的框架，作为分类这些基于细胞和基因修饰的治疗方法的基础。
