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 public comment period for the ST-028 ISBT 128 Standard Chain of Identity Identifier v1.0.0 document will be from July 25 to August 22. CTCLAG members will help with the distribution and notification of the ST-028 comment period. The Chain of Identity Identifier will provide the ability to link multiple collections/donations associated with a therapy or therapies together. ICCBBA plans to publish a new standards document, a new implementation guide, and update ST-001 along with relevant documents in support of the Chain of Identity Identifier. 

 

CTCLAG is currently working on developing ISBT 128 terminology and codes for exosomes. The group plans to consult with the ISCT Exosomes Committee and the International Society of Extracellular Vesicles (ISEV) about this topic.

 

The group is actively discussing the possibility of removing restrictions on the implementation of Product Divisions [Data Structure 032]. The group will distribute a survey to assess the current utilization of the data structure. AABB, FACT, NMDP, and WBMT will help to distribute the survey.

 

ICCBBA’s Technical Director spoke at the Supply Chain & Logistics for Cell Therapies Summit held in April. The topic for implementation of labeling standards to facilitate apheresis collection was well received and there was a general emphasis on the ongoing need for standardization.

 

The proposal for a hybrid ISBT 128/sponsor label for apheresis collections as starting products for clinical trial products was approved and published in the ST-018 document. The hybrid label has the ISBT 128 Donation Identification Number (DIN) and Product Code information on the left half, and the right half of the label will contain standardized sponsor-required information.

 

Clinical trial facilities and study sponsors can request Product Description Codes (PDCs) for their clinical trial products for a specific trial. ICCBBA will issue PDCs specifically for clinical trial products as requests are received and maintain these codes in a separate Clinical Trials PDC Database.

 

The group has discussed how to code and label HPC, APHERESIS that is CD34 enriched but has a specific concentration of T-cells from the negative fraction added back to the product. It was recognized that this product had enough clinical significance to differentiate it from other CD34 enrich products.  CTCLAG decided to create a new attribute to account for the T cells added back. This will result in new product description codes being added to the database.

 

CTCLAG meets monthly due to the rapidly evolving nature of the field.

 

ICCBBA is incorporating the use of Loomio to facilitate asynchronous TAG discussions.

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

  • David Barwin

  • Geoff Browne

  • Tim Costello

  • Jeff Dragoo

  • Clement Glinkowski

  • John Gorowsky

  • Kimberly Jimenez

  • Kent Kirimli

  • Brian Kirkpatrick

  • John Kling

  • Dan Leberfinger

  • Rob Margolin

  • Ana Negrão 

  • Renata Rocha

  • David Steiner

  • Joe Vitale

  • Daniel Waurzyniak

  • Renae Weaver

  • Tomasz Wojcicki

  • Bruce Wray

Liaisons

  • Francisca Agbanyo  – Health Canada

  • TBD – European Commission

  • Safa Karandish – U.S. Food and Drug Administration

  • Izabela Uhrynowska-Tyszkiewicz – ITTAG

ICCBBA Staff Liaison

  • Erwin Cabana