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.  Recently added terminology include the new class name of MSC, DECIDUA (Mesenchymal Stromal Cells derived from Decidua), and a new cryoprotectant attribute for Propylene Glycol. The group is currently discussing coding options for CD34 enriched products that have specific concentrations of T cells added back to the product.

A subcommittee within the group has been formed that will focus on publishing the work that CTCLAG has accomplished. 

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

Chair

  • Zbigniew Szczepiorkowski

Representatives 

  • Sallie Allman - Be the Match
  • Christina Celluzzi - American Association of Blood Banks
  • Betty Doggett - American Society for Apheresis 
  • Lydia Foeken - World Marrow Donor Association
  • Marcos Hernández - Latin American Bone Marrow Transplantation Group
  • Dr. William Hwang - Asia Pacific Blood and Marrow Transplantation
  • William Janssen - American Society for Transplantation and Cellular Therapy
  • Mickey Koh - International Society of Blood Transfusion 
  • Julia Palma - Latin American Bone Marrow Transplantation Group (Alt.)
  • Jared Schuster - Be the Match (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

  • Joshua Geary
  • Kathy Loper
  • Anna Persson

Liaisons

  • Francisca Agbanyo - Health Canada
  • TBD - European Commission
  • Safa Karandish - U.S. Food and Drug Administration

Observers

  • Geoff Browne
  • Tim Costello
  • Jeff Dragoo
  • Clement Glinkowski
  • John Gorowsky
  • Kent Kirimli
  • Brian Kirkpatrick
  • John Kling
  • Richard Kriozere
  • Rob Margolin
  • Teresa Oliveira
  • David Steiner
  • Izabela Uhrynowska-Tyszkiewicz
  • Joe Vitale
  • Daniel Waurzyniak
  • Renae Weaver
  • Tomasz Wojcicki
  • Bruce Wray

ICCBBA Staff Liason

  • Erwin Cabana

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