Cellular Therapy Coding and Labeling Advisory Group
OVERVIEW
The Cellular Therapy Coding and Labeling Advisory Group (CTCLAG) was established in 2004. Its purpose is to advise ICCBBA of the needs of cellular therapy organizations for coding and labeling. Membership comprises representatives from major cellular therapy professional organizations: AABB, APBMT, ASTCT, ASFA, EBMT, FACT, ISBT, ISCT, JACIE, NMDP and WMDA. Additionally, the group has invited technical experts to serve as voting members on the group.
Liaisons from other organizations, primarily representing regulatory bodies, also attend meetings.
Vendors and other interested parties attend meetings as observers at the discretion of the chairperson.
CTCLAG Joint Statement - PDF
SUMMARY OF RECENT ACTIVITY
The new ST-028 ISBT 128 Standard Chain of Identity Identifier v1.0.0 was published in December 2022. This document is accessible to the public at isbt128.org/st-028. The Chain of Identity Identifier provides the ability to link multiple collections/donations associated with a therapy or therapies. The purpose of the ST-028 document is to provide:
-
specifications for the structure of the Chain of Identity (CoI) Identifier
-
information on how to obtain and update a Facility Identification Number (FIN)
-
rules on the use of the ISBT 128 CoI Identifier
ICCBBA has identified several opportunities to raise awareness of the new Chain of Identity Identifier Standard. These include submitting abstracts for presentations, planning webinars, and creating posts on the ICCBBA website/social media pages. CTCLAG members are engaged in these efforts by assisting with newsletter announcements and contributing to the Implementation Guide document as well as abstract and webinar opportunities.
CTCLAG voted to approve the new Cell Therapy attribute for Gamma Delta T cell enriched and the attribute has been added to the database.
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.
CTCLAG is currently working on developing ISBT 128 terminology and codes for exosomes. The group plans to consult with the International Society of Extracellular Vesicles (ISEV) and the ISCT Exosomes Committee about this topic.
CTCLAG meets monthly due to the rapidly evolving nature of the field.
CTCLAG MEMBER LIST
Chair
-
Zbigniew Szczepiorkowski
Representatives
-
Tamara Anderson - National Marrow Donor Program (NMDP) / Be the Match (Alt.)
-
Christina Celluzzi - Association for the Advancement of Blood & Biotherapies
-
Lou J. Bartolo - National Marrow Donor Program (NMDP) / Be the Match
-
Betty Doggett - American Society for Apheresis
-
Lydia Foeken - World Marrow Donor Association
-
Marcos Hernández - Latin American Bone Marrow Transplantation Group
-
William Hwang - Asia Pacific Blood and Marrow Transplantation
-
Indreshpal Kaur - American Society for Transplantation and Cellular Therapy
-
Mickey Koh - International Society of Blood Transfusion
-
Julia Palma - Latin American Bone Marrow Transplantation Group (Alt.)
-
Leigh Sims Poston - International Society Cell & Gene Therapy
-
Lex Van Der Gouw - European Group for Blood and Marrow Transplantation/ Joint Accreditation Committee ISCT-Europe & EBMT
-
Phyllis Warkentin - Foundation for the Accreditation of Cellular Therapy
Technical Experts
-
Beth Gardner
-
Joshua Geary
-
William Janssen
-
Kathy Loper
-
Anna Persson
Observers
-
Erica Agy
-
Laurel Anderson
-
David Barwin
-
Geoff Browne
-
Tim Costello
-
Jeff Dragoo
-
Clement Glinkowski
-
John Gorowsky
-
Kimberly Jimenez
-
Kent Kirimli
-
Brian Kirkpatrick
-
John Kling
-
Dan Leberfinger
-
John Muicroft
-
Mikhaila Roe
-
Renata Rocha
-
David Steiner
-
Daniel Waurzyniak
-
Renae Weaver
-
Tomasz Wojcicki
-
Bruce Wray
Liaisons
-
TBD – European Commission
-
Safa Karandish – U.S. Food and Drug Administration
-
Izabela Uhrynowska-Tyszkiewicz – ITTAG
ICCBBA Staff Liaison
-
Erwin Cabana