SUMMARY OF RECENT ACTIVITY

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The ICCBBA Board has approved Indreshpal (Indresh) Kaur as the new chairperson of CTCLAG. Indresh has participated in the group as a Technical Expert and will now be the group’s Chairperson for a three-year term starting in 2024. Zbigniew (Ziggy) Szczepiorkowski concluded his term as Chair of CTCLAG at the end of 2023 but will continue participating in the group as a Technical Expert. ICCBBA expresses gratitude to Indresh for accepting the role of CTCLAG chair and thanks Ziggy for his many years of exceptional service in leading the group.

 

The new IG-050 ISBT 128 Chain of Identity Identifier implementation guide document was published in December 2023. The document supports the ST-028 ISBT 128 Standard Chain of Identity Identifier document published in December 2022. IG-050 provides guidance on the use of the ISBT 128 Chain of Identity Identifier Data Structure [040] and the Chain of Identity Identifier data element ChainOfIdentityIdentifier in compliance with the ST-028 Standard.  ICCBBA extends its appreciation to the IG-050 subcommittee members who contributed to the publication.

 

ICCBBA is seeking out collaborators to share their experiences with their implementation of the hybrid label specified in ST-018 ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing, as well as the CoI Identifier specified in ST-028 ISBT 128 Chain of Identity Identifier. ICCBBA intends to publish an article in a peer-reviewed journal that includes shared implementation experiences from multiple facility perspectives (collection centers, sponsors, manufacturers).  The article will include implementation pain points, process challenges, and successes. ICCBBA intends to include a reference to the article within the IG-050 and ST-018 documents.

 

The Exosome Subcommittee is working to develop ISBT 128 terminology and codes for exosomes. The group plans to collaborate with the International Society of Extracellular Vesicles (ISEV) and the ISCT Exosomes Committee about this topic.

 

The CAR T Cells Subcommittee is discussing terminology to help differentiate the types of CAR T Cells (e.g., BCMA, CD19, CD22, CD30, etc.) on the label without relying solely on accompanying documentation. For instance, a patient can be enrolled in one CAR T Cell protocol, and then have cells collected and cryopreserved in multiple aliquots for future CAR T Cell production. Both types of CAR T Cells can be cryopreserved in the same storage unit with the same DIN. In 2018, CTCLAG recognized that product specificity should be included on the label, but new terminology did not come to fruition. The CAR T Cells Subcommittee will continue to work on establishing new terminology.

 

The IG-003 US Consensus Standard for Cell Therapy document is being updated to align with the changes made to ST-001 ISBT 128 Standard Technical Specification such as the expanded reference tables, new terms (e.g., "Donation" to "Collection" and "Patient ID" to "Recipient ID"). The data structures and label examples were updated to reflect those changes. The reference tables section was also updated. Volunteer representatives from US-based societies offered to help review/update the new version.

 

Newly published Cellular Therapy Terminology

 

Subcategory 1 Class and Definition:

• NC, FLUID - A cell product containing nucleated cells obtained from fluid.

 

Subcategory 2 Classes and Definitions:

• T CELLS, FLUID - A cell product containing T cells obtained from fluid.

• MALIGNANT CELLS, FLUID - A cell product containing malignant cells obtained from fluid.

 

Attribute Group and Definition:

• Fluid Source Location - Provides information on the location within the body from which the fluid was collected. This attribute group is to be used with the classes NC, FLUID; T CELLS, FLUID; MALIGNANT CELLS, FLUID.

 

Attribute Values to be Added Within the Fluid Source Location Attribute Group:

• Not applicable (Default) – The product is not NC, FLUID; T CELLS, FLUID; MALIGNANT CELLS, FLUID so this attribute does not apply.

• Pleural space - The space between the visceral and parietal pleura. Peritoneal cavity - The space between the visceral layer and the parietal layer of the peritoneum. 

• Synovial joint - The joint cavity within the articular capsule of a diarthrosis joint. 

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