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

The group voted for the current Chairman, Ziggy Szczepiorkowski, to continue as Chair.

CTCLAG continues to assess new terminology requests.  Recent ones include Mesenchymal Stromal Cells derived from Decidua, and a new cryoprotectant that does not contain any DMSO.

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. ICCBBA, in coordination with the FDA, have submitted comments to USCDI (US Core Data for Interoperability) to have the MPHO Unique Identifier added to the USCDI required data for EHR traceability records.

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.

The group approved to have a separate Clinical Trials PDC Database.  Clinical trials facilities and study sponsors can request Product Description Codes (PDCs) for their clinical trials products for a specific trial. The use of a local/facility-defined code might not be a suitable option because facilities receiving products from different study sponsors might encounter duplication of the same local code. ICCBBA will issue PDCs specifically for clinical trials products as requests are received. 

CTCLAG Member List

Representatives and Technical Experts

  • Szczepiorkowski, Zbigniew – Chair
  • Allman, Sallie
  • 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
  • Cruz, Jorge Gayoso
  • Karandish, Safa

Observers

  • Browne, Geoff
  • Cetinkaya, Sukru
  • Chahal, Amar
  • Costello, Tim
  • Dragoo, Jeff
  • Gerhard, Kevin
  • Glinkowski, Clement
  • Gomes, Sonia
  • 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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