Internationally Standardized inology for Regenerated Tissue Consultation Document March 2018
Internationally Standardized inology for Regenerated Tissue 2 Introduction There is growing recognition of the need for a globally consistent terminology and a coding system to ensure unique identification of medical products of human origin (MPHO) worldwide. This need has been recognized by the World Health Assembly in 2010, and Resolution WHA63.22 urges member states to encourage the implementation of globally consistent coding systems for human cells, tissues and organs as such in order to facilitate national and international traceability of materials of human origin for transplantation. ICCBBA is an international standards organization in the field of transfusion and transplantation and is a nongovernmental organization in official relations with the World Health Organization. ICCBBA has already developed international consensus terminology for a number of MPHO. The Regenerative Medicine Technical Advisory Group (RMTAG) was formed by ICCBBA to develop an internationally standardized terminology for regenerated tissue. The RMTAG, under the chairmanship of first Dr. Ruth Warwick and then Dr. Ineke Slaper- Cortenbach, has developed the terminology proposed in this document. A limited subset of this terminology has been published in the ISBT 128 Standard inology for Medical Products of Human Origin in order to meet urgent needs of ISBT 128 users. However, comments on both this proposal, and the terminology actually in use, are welcome. The terminology presented is open for public comment and the advisory group welcomes constructive criticism. Following the consultation period, final adjustments will be made before formal publication. Background ISBT 128 is a well-established international coding system for MPHO. It provides a comprehensive and highly flexible system for describing products and assigning product codes suitable for use in bar codes and other electronic communication. The foundation of this system is a terminology that is constructed by international consensus to ensure global consistency in use and understanding. The ISBT 128 product description code database is created using a rules-based system. It uses classes and attributes to describe products, and then assigns each product a unique five-character product description code. Classes are broad descriptions of products. For Regenerated Tissue, examples of proposed classes are REGENERATED EPIDERMIS and REGENERATED CARTILAGE. Attributes provide the means to further describe the product. Attributes are arranged in groups, and within each attribute group there are a number of possible variables, only one of which can be selected. For example, Type of Cells is a group; Keratinocytes is a variable within that group. Where a product does not have a variable assigned from a particular group, the default variable for that group will apply. For example, Not Specified, which means The type of cells within the product is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation, is the default for Type of Cells.
Internationally Standardized inology for Regenerated Tissue 3 The product code is eight characters long (see Figure 1), with the first five characters comprising the product description code. The first character of this code, letter P in Figure 1, signifies it is a regenerated tissue product. The sixth character indicates the collection type (e.g., voluntary, autologous, directed, designated) and the remaining two characters provide a means to uniquely identify multiple occurrences of a product derived from the same collection event. Thus if two products with the same product description code are created during processing, they can be uniquely identified by using A0 and B0 in these two positions. If more divisions are needed than are supported by the last two characters of the product code, another data structure is used. Figure 1 Product Code Collection For more information, please see the following documents on the ICCBBA website: ISBT 128 Standard Technical Specification (ST-001) ISBT 128 Standard inology for Medical Products of Human Origin (ST-002) Implementation Guide: Encoding Product Information [Data Structures 003, 032, 033, and 034] Tissues (IG-020) Implementation Guide: Product Coding [Data Structures 003 and 032] Cellular Therapy (IG-022) Implementation Guide: Use of Product Divisions [Data Structure 032] (IG-023)
Internationally Standardized inology for Regenerated Tissue 4 Consultation This document is being made publically available on the ICCBBA website, and relevant professional bodies have been notified and asked to bring this to the attention of their stakeholders. Proposed terminology is on the following pages. Additional terms will be added as they are requested by users, and such terminology will follow the same format. As you review the terminology, please consider these questions: 1. Should additional class names be added? If so, what classes should be added? 2. Should additional attribute groups be added? If so, what groups should be added? What should the variables for these groups be? 3. Should additional attribute variables be added to the proposed groups? If so, what should these variables be? Additional comments are also welcome. Feedback should be submitted by May 11, 2018 to the following URL: https://www.iccbba.org/tech-library/proposals/terminology-proposals/terminology-for-regenerated-tissue The advisory group will review all comments prior to finalizing the terminology.
Internationally Standardized inology for Regenerated Tissue 5 Regenerated Tissue inology Regenerated tissue would be defined as: Viable cells constructed into a tissue or seeded onto a scaffold. The template used in the ISBT 128 terminology would be the word Regenerated followed by the type of tissue structure. If there is not a specific structure or type of tissue, the term Regenerated Tissue would be used. Proposed Classes: REGENERATED CARTILAGE REGENERATED CORNEAL EPITHELIUM REGENERATED DERMIS REGENERATED ELASTIC CARTILAGE REGENERATED EPIDERMIS REGENERATED FIBROCARTILAGE REGENERATED HYALINE CARTILAGE REGENERATED LIVER TISSUE REGENERATED ORAL MUCOSA REGENERATED SKIN REGENERATED TISSUE REGENERATED TRACHEA Viable cells constructed into cartilage. Viable cells constructed into corneal epithelium. Viable cells constructed into dermis. Viable cells constructed into elastic cartilage. Viable cells constructed into epidermis. Viable cells constructed into fibrocartilage. Viable cells constructed into hyaline cartilage. Viable cells constructed into liver tissue. Viable cells constructed into oral mucosa. Viable cells constructed into skin. Viable cells in a scaffold without a named tissue structure. Viable cells seeded onto a trachea or trachea segment scaffold. Proposed Attribute Groups: Type of Cells Source of Cells Origin of Scaffold Scaffold Degradability Storage Temperature Delivery Method Ancillary Substances Excipients Describes the primary type of cells used to create the product. Specifies the source of the cells. Specifies the origin of the scaffold. (The scaffold is the support for cells enabling a 2-D or 3-D structure.) Specifies whether the scaffold will stay in place or be degraded. Describes the storage temperature range. Describes the form of the product for implantation. Indicates the presence of substances used during the manufacturing of products that may not be entirely removed. Indicates the presence of inactive ingredients that were added during product formulation.
Internationally Standardized inology for Regenerated Tissue 6 Proposed Attribute Variables: Type of Cells Group Keratinocytes Chondrocytes Hepatocytes Epithelial Cells Melanocytes Fibroblasts Urothelial Cells MSC Multiple Cell Types The type of cells within the product is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. Keratinocytes are the primary cell type present in the product. Chondrocytes are the primary cell type present in the product. Hepatocytes are the primary cell type present in the product. Epithelial cells are the primary cell type present in the product. Melanocytes are the primary cell type present in the product. Fibroblasts are the primary cell type present in the product. Urothelial cells are the primary cell type present in the product. Mesenchymal stromal cells are the primary cell type present in the product. Multiple cell types are present in the product. Source of Cells Group Adipose Tissue Umbilical Cord Cord Blood Bone Marrow The source of cells is not specified in the coding. Adipose tissue is the source of the primary cells in the product. Umbilical cord is the source of the primary cells in the product. Cord blood is the source of the primary cells in the product. Bone marrow is the source of the primary cells in the product. Origin of Scaffold Group Autologous Allogeneic Xeno Synthetic Scaffold type is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. The scaffold is formed from decellularized tissue from the intended recipient. The scaffold is formed from decellularized human tissue not from the intended recipient. The scaffold is formed from decellularized non-human animal tissue. The scaffold has been formed by chemical synthesis and does not contain human or animal materials.
Internationally Standardized inology for Regenerated Tissue 7 Scaffold Degradability Group Default: Not applicable/not specified Degradable Not degradable Not applicable because the regenerated tissue product does not contain a scaffold, or information about the composition of the scaffold is not encoded. Scaffold intended to be degraded or metabolized. Scaffold intended to remain as a permanent or semi-permanent structure. Storage Temperature Group RT Refg Cryopreserved The storage temperature is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. Room temperature The product is to be stored at room temperature. Specific ranges may be specified by national authorities. Refrigerated The product is to be stored at refrigerated temperatures. Specific ranges may be specified by national authorities. Cryopreserved The product contains cryoprotectant(s) and is to be stored in the frozen or vitrified state. Further details may be stated in text on the label or in the accompanying documentation. Delivery Method Group Sheet The method of delivering the implanted cells is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. The product is presented as a sheet. Ancillary Substances Group Ancillary substances: Yes The presence of ancillary substances is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. Ancillary substances are present in the product. Further details may be stated in text on the label or in the accompanying documentation.
Internationally Standardized inology for Regenerated Tissue 8 Excipients Group Excipients: Yes Excipients: Yes, including animal origin The presence of excipients is not specified in the coding. Details may be stated in text on the label or in the accompanying documentation. Excipients are present in the product. Further details may be stated in text on the label or in the accompanying documentation. Excipients, including excipients of animal origin, are present in the product. Further details may be stated in text on the label or in the accompanying documentation.
Internationally Standardized inology for Regenerated Tissue 9 Figure 2 Illustration of the classes and attribute groups utilized for coding Regenerated Tissue. For each product, only one class and one attribute variable per attribute group can be selected. When the attribute is selected, it does not need to be included in the product description. In this example, the entire product description is REGENERATED EPIDERMIS Keratinocytes Sheet Ancillary substances: Yes.
Internationally Standardized inology for Regenerated Tissue 10 Regenerative Medicine Technical Advisory Group Participants Ineke Slaper-Cortenbach [Current Chair] Ruth Warwick [Former Chair] Francisca Agbanyo Julie Allickson John Armitage Jacques Galipeau Martin Hildebrandt Alyce Jones Mickey Koh Marina Maréchal Leigh Sims Poston Zbigniew Szczepiorkowski Izabela Uhrynowska-Tyszkiewicz Diane Wilson Paul Ashford Mónica Freire