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Practice Guideline
. 2022 Dec;28(12):795-801.
doi: 10.1016/j.jtct.2022.08.029. Epub 2022 Sep 2.

Nomenclature for Cellular and Genetic Therapies: A Need for Standardization

Akshay Sharma  1 , Stephanie Farnia  2 , Folashade Otegbeye  3 , Amy Rinkle  2 , Jugna Shah  2 , Nirali N Shah  4 , Saar Gill  5 , Marcela V Maus  6
Affiliations
Practice Guideline

Nomenclature for Cellular and Genetic Therapies: A Need for Standardization

Akshay Sharma et al. Transplant Cell Ther. 2022 Dec.

Abstract

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.

Keywords: Cellular therapy; Gene therapy; Immune effector cell therapy.

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Figures

Figure 1:
Figure 1:
Two models of classification of cellular and gene therapies.
Figure 2:
Figure 2:
Proposed schematic of hierarchy and classification of CGT products.
See this image and copyright information in PMC

References

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    1. Foundation for the Accreditation of Cellular Therapy, The Joint Accreditation Committee – ISCT and EBMT. Standards for Immune Effector Cells. First Edition ed: The Foundation for the Accreditation of Cellular Therapy; 2018.

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