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
ICCBBA has drafted a proposal to add the Chain of Identity Identifier to the ISBT 128 Standard to have a standard system for identifying CoI information for all starting material types for efficient and consistent tracking of cell therapy products derived from a specific patient throughout the collection, production, and delivery process. The proposed solution is to have a globally unique identifier managed by ICCBBA that works by using the FIN appended to the beginning of the identifier. If the proposal is approved, ICCBBA will publish a standards document, a new implementation guide, and update ST-001.
The group is assessing the impact of removing the restrictions on the general distribution of products that utilize the Product Divisions [Data Structure 032].
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.
The committee discussed a request for a new class name of MSC, APHERESIS for a cell product containing mesenchymal stromal cells isolated from a MNC apheresis collection. After discussing the request and obtaining input from the ISCT MSC Committee, CTCLAG decided not to pursue the new class name at this time.
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 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.
Clinical trials facilities and study sponsors can request Product Description Codes (PDCs) for their clinical trials products for a specific trial. ICCBBA will issue PDCs specifically for clinical trials products as requests are received and will maintain these codes in a separate Clinical Trials PDC Database.
No face-to-face meetings are currently scheduled for CTCLAG.
• Zbigniew Szczepiorkowski
• 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
• 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
• 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
• Joshua Geary
• Kathy Loper
• Anna Persson
• Geoff Browne
• Tim Costello
• Jeff Dragoo
• Clement Glinkowski
• John Gorowsky
• Kent Kirimli
• Brian Kirkpatrick
• John Kling
• Dan Leberfinger
• Rob Margolin
• Teresa Oliveira
• David Steiner
• Joe Vitale
• Daniel Waurzyniak
• Renae Weaver
• Tomasz Wojcicki
• Bruce Wray
• Francisca Agbanyo – Health Canada
• TBD – European Commission
• Safa Karandish – U.S. Food and Drug Administration
• Izabela Uhrynowska-Tyszkiewicz – ITTAG
ICCBBA Staff Liaison
• Erwin Cabana