template) on donor consent for the donation of cells for purposes other than traditional HSCT donation. This guidance aims to provide registry members with the tools to address consent and the sharing of research information in the right manner, at the right time, and in the right format. This document can be adapted to local regulations. 2023 WMDA Cellular Therapy Committee - Consent Working Group Output.pdf | Current (2024) |
Donor search request WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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2.07 | Global Development | Recruitment, training, and ongoing educational requirements for donor registry search coordinators | Recommendations by WMDA accredited registries on education of registry staff. Survey was performed in 2009. | Current (2024) | 7.01 | Donor Care | WMDA Guidelines for subsequent donations following initial BM or PBSCs Bone Marrow Transplantation (2011) 46: 1409-1412 | This guideline is intended to outline where subsequent donations would routinely be considered appropriate (from the donor's point-of-view), as well as the frequency and timing of such donations. The background is outdated, the recommendations are current, the data are outdated and the survey information is outdated. | Under review, see https://share.wmda.info/x/8qWbEw for more information | 3.03, 3.06, 6.06 | Donor Care | Donor commitment and patient needs Bone Marrow Transplantation (2004) 33: 225-230 | This paper describes ethical issues related to the donation of hematopoietic stem cell products with respect to recruitment, evaluation, workup, and follow-up of unrelated donors. | Current (2021) |
| Global Development | WMDA Forms | Forms for each step in the search process; WMDA forms will not be updated till the infrastructure of WMDA connect has been implemented. The goal is to generate the forms automatically through HTML code instead of fillable PDFs. | Current (2020) |
| Donor Care | Addressing Ethical and Procedural Principles for Unrelated Allogeneic Hematopoietic Progenitor Cell Donation in a Changing Medical Environment | In this paper, ethical and procedural principles in the context of HPC donation and requests for nonstandard donations are further clarified based on examples from daily practice. The goal is twofold: to provide guidance on applying ethical principles and to create a basis for awareness and understanding for the position of HPC adult volunteer donors and the organizations providing HPCs from these donors in the dynamic field of allogeneic HSCT, by posing questions. | Current (2021) |
Collection and transportationWMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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8.05 | Donor Care | Recommendation for recombinant human G-CSF (G-CSF) that stem cell registries can use - the use of biosimilar G-CSF | WMDA recommendation on the use of biosimilar filgrastims. | Current (2018) | 8.05 | Donor Care | Current use of biosimilar G-CSF for haematopoietic stem cell mobilisation
Bone Marrow Transplantation (2019): 54, 858-866
| WMDA recommends that stem cell donor registries can use filgrastim biosimilars for the mobilisation of peripheral blood progenitor cells in healthy donors, provided that they are approved by national and/or regional agencies. | Current (2019) | 3.03 | Donor Care | Remuneration of hematopoietic stem cell donors: principles and perspective of the World Marrow Donor Association. Blood (2010) 117: 21-25 | This paper describes the reasons that the WMDA continues to believe that donors should not be paid due to ethical concerns raised by remuneration, potential to damage the public will to act altruistically, the potential for coercion and exploitation of donors, increased risk to patients, harm to local transplantation programs and international stem cell exchange, and the possibility of benefiting some patients while disadvantaging others. | Current (2024) | 1.08 | Quality | Audits of collection and apheresis centers: guidelines by the World Marrow Donor Association Working Group Quality and Regulation Bone Marrow Transplantation (2018) 54: 244–257 | This paper describes the general requirements and recommendations for collaboration with the collection and apheresis centers and defines critical procedures for the collection of the stem cell product, such as the information session, medical assessment, product collection, quality controls, product handover for transportation, and donor follow-up. The specific guidelines are accompanied by detailed checklists and forms that can be found in Supplementary Information and may be used during an initial or follow-up on-site or paper-based audit. | Current (2024) | 8.07.1 | Quality | Introduction and Importance of a Globally Unique Identity and Labelling Format (ISBT-128) Attachment A Attachment B | Currently being updated to accommodate GRID, this position paper encourages the benefit and criticality of a globally unique numbering system, WMDA recognizes the ISBT 128 labelling standard as one that supports full traceability of cellular therapy products from the donor to the patient bedside and the flexibility to protect confidential information as defined by current and future international regulations. | Under review | 8.08 | Quality | World Marrow Donor Association (WMDA) Guidelines for Couriers and the Transportation of Heamatopoietic Progenitor Cells (HPC-BM, Apheresis and Therapeutic Cells- T Cells) | The paper describes recommendations for couriers and the transportation of haematopoietic progenitor cells. | Under review (2024) | 8.08 | Quality | Validation of Product Transportation Containers | This report provides WMDA guidelines for validation of transport containers used for the distribution of HSC products | Current (2018) | SPEAR Communication | Donor Care | 2023/02 SPEAR Communication: Labelling Errors | The SPEAR committee has received reports of adverse events related to mis-labelling. One case resulted in infusion of the wrong product into a patient with a fatal outcome. Two cases related to re-labelling of products with ISBT labels. Mis-labelling adverse events can occur at all steps of the collection and processing pathway. The committee has issued a statement stressing the importance of correct labelling. Read it here: PDC.1301.COMM.Labelling Errors.pdf | Current (2024) | SPEAR Communication | Donor Care | 2023/08 SPEAR Communication: Preventing Unnecessary Donations | The impact of late cancellations on unnecessary donations was discussed with the SPEAR committee. A The critical component missing in the SPEAR cases discussed was closed loop communication. Therefore, the committee would like to highlight the importance of person-person communication to prevent unnecessary donation. The committee will continue to collaborate with the WMDA project group on back-up donors management and supports their soon to be published guidance. Read it here: PDC.1303.COMM.Unnecessary Donations.pdf | Current (2024) | SPEAR Communication | Donor Care | 2024/04 SPEAR Communication: HPC Products Missing in Transport
| The SPEAR Committee received multiple reports of serious incidents involving product loss during transport. Two items were recovered, another was not. To prevent such similar incidents in the future, the SPEAR Committee publishes recommendations on best practices, emphasizing the need for thorough training, the importance of constant visual product control, and an assessment of the courier's readiness for traveling, including their capability for handling complicated journeys, in alignment with WMDA Standards and Transport Guidelines. Additional guidance on, but not limited to, non-air travel management is endorsed by the committee. Read it here: PDC.1305.COMM.HPC Products Missing in Transport.pdf
| Current (2024) |
Post-donationWMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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9.03, 9.04 | Donor Care | Safety of Living Donation of Hematopoietic Stem Cells Transplantation (2016) 100: 1329-1331 | This paper describes a decade of detailed examination of adverse donor events. | Current (2024) | 9.03, 9.04, 5.04.1 | Donor Care | Inadvertent completely HLA-mismatched allogeneic unrelated bone marrow transplant: lessons learned. Bone Marrow Transplantation (2016) 51: 1016-1018 | This paper describes a serious adverse event in which a patient was transplanted with stem cells from an incorrect donor due in large part to the inappropriate use of a supposedly unique donor identifier. | Current (2024) | | Donor Care | Serious Stem Cell Donation Events and Recipient Adverse Reactions Related to Severe Acute Respiratory Syndrome Coronavirus 2: Review of Reports to the World Marrow Donor Association Transplantation and Cellular Therapy (2023) Volume 29, Issue 8, August 2023, Pages 522.e1-522.e5 | This paper provides insight into SARS-CoV-2-related adverse events to the WMDA-operated Serious Product Events and Adverse Reactions (SPEAR) database. The Committee reviewed each report following the European Union definitions of a serious adverse event or reaction and determined the imputability and its impact. Reports submitted in 2020 were included in this analysis. | Current (2024) | | Donor Care | Genetic Findings of Potential Donor Origin following Hematopoietic Cell Transplantation: Recommendations on Donor Disclosure and Genetic Testing from the World Marrow Donor Association (WMDA) Transplantation and Cellular Therapy (2023), doi: https://doi.org/10.1016/j.jtct.2023.11.019 | Provides recommendations and a framework to aid in registry decision-making when genetic mutations of potential donor origin are identified. This includes guidance on pre-donation consenting, post-donation testing of recipients and informing and managing donors when findings of potential donor origin are identified in recipients post-transplantation, aimed at protecting the health, rights, and wellbeing of the donor. | Current (2024) | SPEAR Communication | Donor Care | 2023/02 SPEAR Communication: Near-Miss Donation From Donor With HIV | The SPEAR committee received a report of a case which could have led to HIV transmission: a donor tested negative for HIV but was found to be positive on the day of donation. Based on this case, the committee provides recommendations to help protect donor and patient safety. Read it here: PDC.1302.COMM.Near-Miss Donation From Donor With HIV.pdf | Current (2024) | SPEAR Communication | Donor Care | 2023/08 SPEAR Communication: Subdural Haemorrhage Post-Donation | The SPEAR Committee received various reports of subdural haemorrhage (SDH) in unrelated PBSC donors since the beginning of 2021. The cause of this condition in these donors and the relation to donation is not clear, however the committee feels it is good to share a summary of these events and some of the things that are worth considering regarding donor care. Read it here: PDC.1304.COMM.Subdural Haemorrhage.pdf
| Current (2024) |
Cord blood bankingWMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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5.04.1 | Search, Match & Connect | Global Registration Identifier for Donors (GRID) of Hematopoietic Stem Cells: Road to Automation and Safety Transfusion Medicine and Hemotherapy (2017), 44: 407-413 | An educational paper to explain why GRID is implemented on a global scale. | Current (2024) | 5.04.1 | Search, Match & Connect | GRID: Moving to Unique Donor Identifier | A public webpage with educational materials to implement GRID in a registry. | Current (2024) | 5.02 | Search, Match & Connect | World Marrow Donor Association guidelines for the reporting of novel HLA alleles Jan A. Hofmann, Werner Bochtler, James Robinson, Jürgen Sauter, Medhat Askar, Lucie Houdova, Mark Melchers, Alexander H. Schmidt, Eric Spierings, Christine Urban, Alicia Venter, Martin Maiers, Steven G. E. Marsh, Hans-Peter Eberhard HLA: Immune Response Genetics (2023) DOI:10.1111/tan.15048 | The guidelines for the implementation and reporting of HLA nomenclature for the World Marrow Donor Association have served as a reliable standard for communication of HLA data in the hematopoietic cell transplantation process. Wider use of next-generation sequencing made a special provision of the guidelines increasingly pertinent: how to communicate novel HLA alleles. | Current (2024) | 5.02 | Search, Match & Connect | An update to the HLA Nomenclature Guidelines of the World Marrow Donor Association, 2012 Bochtler W, Maiers M, Bakker JN, Baier DM, Hofmann JA, Pingel J, Rist HG, Oudshoorn M, Marsh SG, Müller CR, Hurley CK; Information Technology Working Group of the World Marrow Donor Association. Bone Marrow Transplantation (2013) 48: 1387-1388 | An update of the paper published in 2007. The update became necessary after the major revision of the WHO HLA nomenclature in April 2010. It now covers issues arising when alleles are withdrawn or renamed because of the continuous updating of the WHO HLA nomenclature. In addition, formal validation and interpretation rules for the so-called ‘multiple allele codes’ have been added. | Current (2024) | 5.15.2 5.16 | Search, Match & Connect | GRID Implementation Plan - Template | This document provide a template developed by the GRID Task Force how to implement GRID in a registry | Current (2024) | 5.15.2 5.16 | Search, Match & Connect | Global Registration Identifier for Donors: ION database and GRID rules | The purpose of this document is to provide: - specifications for the structure of the Global Registration Identifier for Donors (GRID) and the Issuing Organization Number (ION) ;
- information on how to obtain and update an ION ; and,
- rules on the use of the GRID .
| Current (2024) | 5.15.2 5.16 | Search, Match & Connect | ISBT 128 Standard for Coding Medical Products of Human Origin | The purpose of this document is to provide standards and guidance for the coding and labelling of medical products of human origin (MPHO) : blood, cellular therapy , tissue s, regenerated tissue, milk, fecal microbiota, topical products of human origin, in vivo diagnostic MPHO, and organs for transplant , as well as those plasma derivatives for which ABO is relevant | Current (2023) | 5.17 | Search, Match & Connect | World Marrow Donor Association framework for the implementation of HLA matching programs in hematopoietic stem cell donor registries and cord blood banks. Bone Marrow Transplantation (2011) 46:338-343 | This paper defines a comprehensive framework for HLA matching programs, which use intricate algorithms to rapidly select potential donors for a patient from a database and to present these donors in a prioritized list. | Current (2023) |
| Search, Match & Connect | Information technology and the role of WMDA in promoting standards for international exchange of hematopoietic stem cell donors and products. Bone Marrow Transplantation (2010) 45: 839-842 | Overview paper of the activities in the area of information technology, described in 2010. - Standardized reference data sets for validation and plausibility controls for HLA and other data domains
- Matching algorithm standards for determining histocompatibility
- Communication standards between registries.
| Current (2023) | 5.02 | Search, Match & Connect | A comparative reference study for the validation of HLA-matching algorithms in the search for allogeneic hematopoietic stem cell donors and cord blood units. HLA Immune Responds Genetic (2016) 87: 439-448 | A comparison of matching algorithms used different registries. | Under review |
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