CTCLAG


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, ASBMT, 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

A proposal for a hybrid ISBT 128/sponsor label for apheresis collections as starting products for clinical trial products is being discussed. Currently, sponsors use their own labels for their clinical trial collection products and this creates a challenge for collection centers because of the variety of label formats they receive. The proposed label will have 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.

The group discussed the draft proposal “Separate Product Description Codes and Database for Clinical Trials Products”. Clinical trials facilities and study sponsors have requested Product Description Codes (PDCs) for their clinical trials products. Using the same PDCs as for cellular therapy products (S codes) might not be appropriate because these are not mainstream cellular therapy products; these are research products and their use is limited to patients in a specific trial. Alternatively, the use of a local/facility-defined code might not be a suitable option either, because facilities receiving products from different study sponsors might encounter duplication of the same local code. ICCBBA is proposing to issue PDCs specifically for clinical trials products and to create a separate database for registering and managing these PDCs.

The issue of documentation of cellular therapy products in electronic health records is being discussed. The goal is to have traceability information of cellular therapy products in the electronic health records. Members will reach out to different software company groups and asses their progress on the topic of traceability information of cellular therapy products in electronic health records.

CTCLAG voted on the name, “Dual Cell Fusion”, to be applied to cell fusion products that are formed from two cell populations. 

CTCLAG Member List

Representatives and Technical Experts

  • Szczepiorkowski, Zbigniew – Chair
  • Allman, Sallie
  • Cameron, Giovanna
  • Celluzzi, Christina
  • Doggett, Betty
  • Foeken, Lydia
  • Geary, Josh
  • Hernández, Marcos 
  • Hwang, Dr. William
  • Janssen, William
  • Koh, Mickey
  • Loper, Kathy
  • Palma, Julia
  • Persson, Anna
  • Sims Poston, Leigh
  • Van der Gouw, Lex
  • Warkentin, Phyllis

Liaisons

  • Agbanyo, Francisca
  • Hansson, Mona 
  • Karandish, Safa

Observers

  • Alves, Jorge
  • Browne, Geoff
  • Cetinkaya, Sukru
  • Chahal, Amar
  • Costello, Tim
  • Dragoo, Jeff
  • Gerhard, Kevin
  • Glinkowski, Clement
  • Herzberg, Mark
  • Hoppe, Ann
  • Ketari, Kamel
  • Kingsbury, Tracy
  • Kirimli, Kent
  • Kirkpatrick, Brian
  • Kling, John
  • Kriozere, Richard
  • Kriozere, Jeff
  • Margolin, Rob
  • Mendes, Patrick
  • Miller, Creighton
  • Oliveira, Teresa
  • Pereda, Pedro
  • Steiner, David
  • Uhrynowska-Tyszkiewicz, Izabela
  • Vitale, Joe
  • Waurzyniak, Daniel
  • Weaver, Renae
  • Wojcicki, Tomasz
  • Wray, Bruce

 

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