CTCLAG SEEKS COMMENTS ON DRAFT TERMINOLOGY
Since the early nomenclature was developed, the CTCLAG has approved classes and terminology for very innovative products, even for products without “obvious” therapeutic benefit. This became a great concern to the US FDA, who provides a liaison to the CTCLAG. The CTCLAG therefore needed to reconsider the use of TC (therapeutic cells) terminology for products, perform a thorough review of existing nomenclature, and propose new nomenclature for the problematic terms.
CTCLAG is proposing that the terminology be updated with the intent of keeping the number of changes as limited as possible to accommodate the current users and to change it in a way that is in line with other fields, especially tissue banking, that use ISBT 128 terminology.
Major proposed changes are:
- Including the source in the name of the product, separated by a comma from the type of cells
- Deleting the hyphenated class names
- Deleting the TC and therapeutic terminology
- Deleting the use of modifiers and adding this information into attributes.
- Adding new attributes.
To view the proposed revisions to class terminology, click here
View the proposed changes to attribute groups and variables, click here