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| title | WMDA Scientific Publications and Recommendations by subject |
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General Organisation of a Registry| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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| 1.03 | Global Development | Global Trends |
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the WMDAPUBHB.General Organisation of a Registry
| WMDA Standard | Title and link todocument | Explanation | Status |
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1.03 | Global Trends | Report of WMDA | Annual publication presenting the unrelated stem cell donor activity on a global scale. | Current ( |
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20181013Donor and liability of donor registries, donor centres and collection centres-recommendations2004, 33: 467-470The paper outlines the ethical aspects of liability of involved parties and the need for insurance coverage. The article hasshortcomingwith the respect tolegaladvices. | | | 5.04.1 | 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 (2018) |
| 5.04.1 | GRID: Moving to Unique Donor Identifier | A public webpage with educational materials to implement GRID in a registry | Current (2018) |
2.11 2.11.1 | WMDA Quality Manual | A template quality manual for organisations that prepare for WMDA Qualification/Accreditation | Current (2017) |
| Relateddonors | Family donor care management: principles and recommendations Bone Marrow Transplantation (2010) 45: 1269-1273
| This document hopes to encourage increased collaboration between those caring for related and unrelated donors, and build on the extensive work, which has already been undertaken in this field to homogenize care. | Current (2017) |
| Relateddonors | Related hematopoietic cell donor care: is there a role for unrelated donor registries? Bone Marrow Transplantation (2015) 50: 637-641 | Paperoutliningways how to enhanceandhomogeniserelateddonor care and if registries can play a roleincounsellingrelateddonors and collecting their hematopoietic stem cells. | Current (2018) |
| 1.07 | Criteria for Evaluation of Transplant Centres | Develop criteria and a form to evaluate TCs in the following situations: - TC is located in a country without a registry
- TC is not evaluated by the local registry, or current evaluation is not appropriate
- TC is not affiliated with a WMDA qualified or accreditedorganisation
TC does not need toevaluatedif the following apply: - TC is accredited by FACT-JACIE
- TC is affiliated with a WMDA qualified or accreditedorganisation
| Under development |
| 1.06 | Donor centre Audit | Create guidelines and checklists to audit donorcentres | Under development |
Recruitment of volunteer donors
| WMDA Standard | Title and link todocument | Explanation | Status |
|---|
3.13 4.09 | Unrelated hematopoietic stem cell donors as research subjects Bone Marrow Transplantation (2011), 46: 10-13 | Discusses various implications of participation of unrelated stem cell donors in research protocols. | Current (2017) |
3.22 3.22.2 | Unrelated adult stem cell donor medical suitability: recommendations from the World Marrow Donor Association Clinical Working Group Committee.
Bone Marrow Transplantation 49:880-886
Guidance for assessing the medical suitability for adult volunteer donors
The paper provides a background to unrelated adult donor and recipient safety, recommends a common framework for assessing the health of unrelated adult donors at each stage of the donation pathway and presents a novel mechanism for sharing international consensus criteria for individual medical and lifestyle conditions.
The guidance below reflects the consensus opinion provided by the WMDA donor medical suitability committee. The purpose of this guidance is to provide globally harmonised medical assessment criteria which simultaneously protect the interest of donors whilst ensuring the safety of cellular products across international boundaries.
Current (2017)
| 3.02 | Qualifications and training of adult stem cell donor recruiters: recommendations by the World Marrow Donor Association Bone Marrow Transplantation (2013) 48: 1480150 | This paper is providing recommendations regarding qualifications and training of recruiters. At the moment,the onlinerecruitment is not described in this paper. | Update required. |
2.08 | 57:466–472 | Guidelines on how to review a donor centre including a checklist | Current (2024) | | 1.06, 1.07, 1.08 | Global Development | WMDA Guidance for Addition of New Affiliated Entity to a Registry Publication of WMDA Guidance for Cross-border Organisations | Guidelines to incorporate a new affiliated entity (e.g. DC, CBB, TC, CC, commercial courier) base on the level of risk for the registry and for other WMDA members and take steps to reduce o eliminate that risk. Guidelines for organisations that have affiliated donor or patient management entities located in a country different from the country where the parent organisations resides. Recommendations for applying or renewing WMDA Certification/Qualification/Accreditation | Current (2024) | 2.10 2.10.1 | Global Development | WMDA Quality Manual
Notification and request for information regarding problems between registries | A template for a quality manual for registries and cord blood banks.
A template for registry to registry problem management communication. Notification and request for information regarding a problem arising
| Under review (2024)
Current (2020) | 2.10.2 | Global Development | World marrow donor association crisis response, business continuity, and disaster recovery guidelines. Biology of Blood and Marrow Transplantation (2012) 18: 1785-1789 | This paper covers the minimal requirements of preparedness in prevention and mitigation, crisis response, business continuity, and disaster recovery, and the need for continued maintenance and revision. Issues of international cooperation are addressed as well. Visit as well the following webpage: https://share.wmda.info/x/dQAOEw | Current (2020) | | Related donors | Donor Care | Family donor care management: principles and recommendations Bone Marrow Transplantation (2010) 45: 1269-1273 | This publication encourages increased collaboration between those caring for related and unrelated donors. It recommends that related donor care build on the extensive work which has already been undertaken in the unrelated donor field to homogenize care. | Current (2021) | | Related donors | Donor Care | Related hematopoietic cell donor care: is there a role for unrelated donor registries? Bone Marrow Transplantation (2015) 50: 637-641 | Paper outlining ways to enhance and homogenise related donor care and registries can play a role in counselling related donors and in collecting their hematopoietic stem cells. | Current (2018) | | Donor engagement / Cell and Gene Therapy | Donor Care | Resources for Registries on Donor Engagement in CGT | This resource kit is a collection of advice and materials on how to run discussion groups with donors from your registries. It has been designed to explore the broad theme of cell and gene therapy (including working with external organisations, sourcing starting material from donors, cryopreservation, etc.), and touches on a range of key topics that are of interest to us as a wider community. | Current (2024) | | 1.07 | Global Development | WMDA Criteria and Process for Transplant Center Evaluation | CONDITIONS for EVALUATION A Transplant Center does not need to be evaluated for WMDA Search & Match Service access if the following apply: - TC is currently affiliated/has a written agreement with a registry qualified or accredited by WMDA
- TC is currently accredited by FACT-JACIE
The WMDA criteria may be used by a registry to evaluate a TC under one or more of the following situations: - TC is located in a country without a registry
- TC is located in a country with a registry that does not have its own criteria for evaluating transplant centers
- TC is not affiliated with a registry qualified or accredited by WMDA
- TC is not evaluated according to WMDA Standard 1.07.1
MATERIALS FOR WMDA CRITERIA and EVALUATION OF TRANSPLANT CENTERS | Current (2024) |
Recruitment and evaluation of volunteer donors| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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| 2.08 | Quality |
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| Key Performance Indicators for Registries | WMDA has defined five Key Performance Indicators (KPI) that represent the key activities of stem cell donor registries. These key performance indicators are calculated annually from the WMDA Global Trends Report data. | Current ( |
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201803, 3.04, 3. is providing | provides information about the donor care standards of the WMDA. The paper |
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has been | was published in 2010, the wording of the WMDA Standards |
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might | have changed over time. | Current ( |
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2017)Addressing Ethical and Procedural Principles for Unrelated Allogeneic Hematopoietic Progenitor Cell Donation in a Changing Medical Environment | Current (2018) | Donor search request
| WMDA Standard | Title and link todocument | Explanation | Status |
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2.07 | Recommendation on the training of staff performing patient donor search and HLA matching activities | Recommendations by WMDA accredited registries oneducationof registry staff.Surveyis done in 2009. | Update review, contact Irina Evseeva |
7.01 | 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:8qWbEwfor more information
| 3.03, 3.06, 6.06 | 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 (2017) |
WMDA Forms | Forms for each step in the search process | Current (2018) | Collection and transportation
| WMDA Standard | Title and link todocument | Explanation | Status |
|---|
8.05 | 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 ofbiosimilarfilgrastims | Current (2018) |
8.05 | Current use of biosimilar G-CSF for haematopoietic stem cell mobilisation
Bone Marrow Transplantation (2018)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 (2018) | | 3.03 | 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 HSC 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 (2017) |
| 1.08 | Audits of collection and apheresis centers: guidelines by the World Marrow Donor Association Working Group Quality and Regulation Bone Marrow Transplantation (2018) | This paper describes the general requirements and recommendations for collaboration with the collection and apheresis centers and define critical procedures for the collection of the stem cell product, such as 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. For more information you can visit: https://share.wmda.info/x/OAKQEQ | Current (2018) |
| 8.07.1 | Introduction and Importance of a Globally Unique Identity and Labelling Format (ISBT-128) Attachment A Attachment B | 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 revision. Paper is from 2010. Susie Joron |
| 8.08 | World Marrow Donor Association (WMDA) Guidelines for Couriers and the Transportation of Haemopoietic Progenitor Cells (HPC-BM, Apheresis and Therapeutic Cells- T Cells) | The paper describes recommendations for couriers and the transportation of haematopoietic progenitor cells. | Current (2017) |
| 8.08 | Validation of Product Transportation Containers | Develop WMDA guidelines for validation of transport containers used for the distribution of HSC products | Current (2018) |
8.07 | Circular of Information for the Use of Cellular Therapy Products | The Circular of Information (Circular) for the Use of Cellular Therapy Products is intended to be an extension of the cellular therapy product label. It has been jointly prepared by the AABB Circular of Information Cellular Therapies Task Force, which includesacollaborativegroup of multiple nongovernmental organizations that represent the cellular therapy field. The US Food and Drug Administration and the Health Resources and Service Administration also participated in the development and review process. The Task Force intentionally limited its scope to only include minimally manipulated cellular therapy products such as peripheral blood progenitor cells, bone marrow, cord bloodand leukocytes. The group recognizes there are multiple cellular therapy products that could not be adequately covered in the Circular. To accommodate this, the Circular includes multiple blank pages at the end of the document to allow for the addition of productorfacility specific information.
Donor search request | WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|
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. | Current (2024) | | 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 transportation| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|
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-donation| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|
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 banking| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|
GDPR | Search, Match & Connect | Recommendation on Data Minimisation | Data minimisation is a fundamental principle in data protection and privacy law, emphasising the collection and processing of only the essential data required for a specific purpose. This principle aims to mitigate risks associated with data breaches and misuse by ensuring that unnecessary personal data is neither gathered nor retained.
The data minimisation principle is prescribed by various regulations, all expressing that personal data must be "adequate, relevant, and limited to what is necessary in relation to the purposes for which they are processed" (e.g., Article 5(1)(c) of the GDPR, Article 4(1)(c) of Regulation (EU) 2018/1725, the minimum necessary rule of HIPAA, and as best practice in the NIST SP 800-122 guide to protecting the confidentiality of personal identifiable information (PII)). | Current (2024) | 5.05, 5.10, 5.24, 5.25 | Search, Match & Connect | Recommendation on Data Retention and Destruction | This recommendation sets out guidelines for retaining personal data, specifying how long different types of data should be kept and under what circumstances they should be deleted. It also outlines measures to ensure personal data is stored securely during its retention period, such as specifying the type of encryption or access controls that need to be implemented. This is a high-level overview as the member’s policy should be drafted taking into account each one's national legal/regulatory requirements.
In addition to retention guidelines, this recommendation provides guidance on data destruction methods, such as shredding or secure deletion using software tools. It also specifies the frequency and circumstances for data destruction. | Current (2024) | 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 |
Publications in partnership with other professional societies | WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|
| Donor Care | Suitability of haematopoietic cell donors: updated consensus recommendations from the WBMT standing committee on donor issues - The Lancet Haematology) The Lancet (2022) DOI:https://doi.org/10.1016/S2352-3026(22)00184-3 | The contribution of related donors to the globally rising number of allogeneic haematopoietic stem cell transplantations (HSCT) remains increasingly important, particularly because of the growing use of haploidentical HSCT. Compared with the strict recommendations on the suitability for unrelated donors, criteria for related donors allow for more discretion and vary between centres. In 2015, the donor outcome committee of the Worldwide Network for Blood and Marrow Transplantation (WBMT) proposed consensus recommendations of suitability criteria for paediatric and adult related donors. This Review provides updates and additions to these recommendations from a panel of experts with global representation, including the WBMT, the European Society for Blood and Marrow Transplantation donor outcome committee, the Center for International Blood and Marrow Transplant Research donor health and safety committee, the US National Marrow Donor Program, and the World Marrow Donor Association, after review of the current literature and guidelines. Sections on the suitability of related donors who would not qualify as unrelated donors have been updated. Sections on communicable diseases, clonal haematopoiesis of indeterminate potential, paediatric aspects including psychological issues, and reporting on serious adverse events have been added. The intention of this Review is to support decision making, with the goal of minimising the medical risk to the donor and protecting the recipient from transmissible diseases. | NA |
| Foundation | Position paper on Unproven Cell-Based Therapies: Current Global Status and Recommendations to the World Health Organization | Direct-to-consumer marketing of unproven cell-based interventions has progressively become a global serious public health concern. Among cell therapeutics we can broadly distinguish immune cells (unmodified or gene modified natural killer T-cells) and stem cell-based interventions. Currently, there is a limited number of both immune and stem cell products with market authorization1 and the current state of scientific evidence does not justify the use of most cell-based interventions outside of well-designed, strictly supervised and regulated clinical research studies. | NA | | 8.07 | Quality | Circular of Information for the Use of Cellular Therapy Products
| The Circular of Information (Circular) for the Use of Cellular Therapy Products is intended to be an extension of the cellular therapy product label. It has been jointly prepared by the AABB Circular of Information for Cellular Therapy Products Task Force, which includes a collaborative group of multiple nongovernmental organizations that represent the cellular therapy field. The US Food and Drug Administration and the Health Resources and Service Administration also participated in the development and review process. The Task Force intentionally limited its scope to only include minimally manipulated cellular therapy products such as peripheral blood progenitor cells, bone marrow, cord blood and leukocytes. The group recognizes there are multiple cellular therapy products that could not be adequately covered in the Circular. To accommodate this, the Circular includes multiple blank pages at the end of the document to allow for the addition of product or facility specific information. | (Current 2024) |
| Foundation | Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. Bone Marrow Transplantation (2016) 51: 778–785 | Paper outlining the transplant activity from 2006 till 2012. | NA | 9.02 | Donor Care | Allogeneic hematopoietic stem cell donation-standardized assessment of donor outcome data: a consensus statement from the Worldwide Network for Blood and Marrow Transplantation (WBMT). Bone Marrow Transplantation (2012) 48: 220-225 | Global consensus document to perform long-term follow up on donors asses the impact of novel agents given to donors. | NA | 3.22 3.22.3 | Donor Care | Suitability Criteria for Adult Related Donors: A Consensus Statement from the Worldwide Network for Blood and Marrow Transplantation Standing Committee on Donor Issues. Biology of Blood and Marrow Transplantation (2015) 21: 2052-2060 | Global consensus document with recommendations for donor workup and final clearance of family donors who would not be able to serve as unrelated donors because of their age or pre-existing diseases. This article covers different topics intending to support decision-making, with the goal of minimizing medical risk to the donor and protection of the recipient from transmissible diseases. | NA |
| Quality | Definitions of histocompatibility typing terms Blood (2011) 118: 180-183
Definitions of histocompatibility typing terms: Harmonization of Histocompatibility Typing Terms Working Group Human Immunology (2011) 12: 1214-1216 | The papers define terms for HLA typing resolution, HLA matching, and a format for reporting HLA assignments. In addition, definitions of verification typing and extended typing are provided. | NA | | 4.02 | Global Development | Family-directed Umbilical Cord Blood Banking Haematologica (2001) 96: 1700-1707 | Educational paper about the distinction of different types of cord blood banking. | NA |
| Global Development | "Worldwide Network for Blood & Marrow Transplantation (WBMT) special article, challenges facing emerging alternate donor registries” Bone Marrow Transplantation (2019) | Paper outlining the challenges for emerging donor registrries | NA |
| Foundation | Recommendations to Improve the Quality and Safety of Medical Products of Human Origin, as an outcome of the Forum 25 meeting held in Lisbon, Portugal in September 2019. |
| NA |
Archived Publications |
Current (2018) | Post-donation
| WMDA Standard | Title and link todocument | Explanation | Status |
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9.03, 9.04 | Safety of Living Donation of Hematopoietic Stem Cells Transplantation (2016) 100: 1329-1331 | This paper describes a decade ofdetailedexamination of adverse donor events. | Current (2018) |
| 9.03, 9.04, 5.04.1 | 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 (2018) |
| 9.03, 9.04 | Towards a global system of vigilance and surveillance in unrelated donors of haematopoietic progenitor cells for transplantation. Bone Marrow Transplantation (2013) 48: 1506-1509
| This paper described that WMDA has successfully implemented a reporting system for serious adverse events and reactions. | Current (2018) |
Cord Blood Banking
| WMDA Standard | Title and link todocument | Explanation | Status |
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Combined Private and Public Cord Blood Banking and Other Related Products | Guiding principles for cord blood banks that operate a public and private inventory | Under review (2018) | WMDA Policy Statement on the Utility of Autologous or Family Cord Blood Unit Storage | WMDA policy statement on private cord blood banking | Under review (2018) | Recommendation for use of cord blood samples by cord blood banks and transplant centres | Discussion paper for cord blood banks how to handle reservation requests for attached segments | Under review (2018) | | WMDA Standard | Title and link todocument | Explanation | Status |
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2.11.2 | World marrow donor association crisis response, business continuity, and disaster recovery guidelines. Biology of Blood and Marrow Transplantation (2012) 18: 1785-1789 | This paper cover the minimal requirements of preparedness in prevention and mitigation, crisis response, business continuity, and disaster recovery, and the need for continued maintenance and revision. Issues of international cooperation are addressed as well. Visit as well the following webpage: https://share.wmda.info/x/dQAOEw | Current (2017) |
3.20 4.16 | A special report: histocompatibility testing guidelines for hematopoietic stem cell transplantation using volunteer donors.
Human Immunology (1999) 60: 347-360
Histocompatibility testing guidelines for hematopoietic stem cell transplantation using volunteer donors: report from The World Marrow Donor Association
Bone Marrow Transplantation 24: 119-121
A special report: histocompatibility testing guidelines for hematopoietic stem cell transplantation using volunteer donors
Tissue Antigens (1999) 53: 394-406
To provide recommendations on the HLA typing of donors. | Under revision user-62c43 | | 5.02 | An update to the HLA Nomenclature Guidelines of the World Marrow Donor Association, 2012 Bone Marrow Transplantation (2013) 48: 1387-1388 | An update from 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 (2017) |
| 5.02 | World Marrow Donor Association Guidelines for Use of HLA Nomenclature and Its Validation in the Data Exchange Among Hematopoietic Stem Cell Donor Registries and Cord Blood Banks 2012 | This supplemantory document provides the entire updated information originally found in the publication: World Marrow Donor Association guidelines for use of HLA nomenclature and its validation in the data exchange among hematopoietic stem cell donor registries and cord blood banks | Current (2017) |
| 5.17 | 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 (2017) |
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 (2017) | | 5.02 | 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 paper to make sure that the matching algorithms used are correct. | Current (2017) |
Finance and administration
| WMDA Standard | Title and link todocument | Explanation | Status |
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Publications in partnership with other professional societies
| WMDA Standard | Title and link todocument | Explanation | Status |
|---|
Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. | Paper outlining the transplant activity from 2006 till 2012. | Current (2017) | 9.02 | Allogeneic hematopoietic stem cell donation-standardized assessment of donor outcome data: a consensus statement from the Worldwide Network for Blood and Marrow Transplantation (WBMT). Bone Marrow Transplantation (2012) 48: 220-225 | Global consensus document to perform long-term follow up on donors till 10 years after donation. | Current (2017) |
3.22 3.22.3 | Suitability Criteria for Adult Related Donors: A Consensus Statement from the Worldwide Network for Blood and Marrow Transplantation Standing Committee on Donor Issues. Biology of Blood and Marrow Transplantation (2015) 21: 2052-2060 | Global consensus document with recommendations for donor workup and final clearance of family donors who would not be able to serve as unrelated donors because of their age or pre-existing diseases. This article covers different topics intending to support decision-making, with the goal of minimizing medical risk to the donor and protection of the recipient from transmissible diseases. | Current (2017) |
Definitions of histocompatibility typing terms
Blood (2011) 118: 180-183
Definitions of histocompatibility typing terms: Harmonization of Histocmpatiblity Typing Terms Working Group
Human Immunology (2011) 12: 1214-1216
The papers define terms for HLA typing resolution, HLA matching, and a format for reporting HLA assignments. In addition, definitions of verification typing and extended typing were addressed. | Current (2018) | | 4.02 | Family-directed Umbilical Cord Blood Banking Haematologica (2001) 96: 1700-1707 | Educational paper about the distinction of different types of cord blood banking. | Current (2017) |
"Worldwide Network for Blood & Marrow Transplantation (WBMT)special article, challenges facing emerging alternate donor registries” | Paper outlining the challenges for emerging donor registrries | Current (2019) | Archived Publications
| WMDA Standard | Title and link todocument | Explanation | Status |
|---|
A gift for life (paper edition) | This is the first print of the WMDA Handbook for registries; it has been replaced |
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by an online editionOut of date | A gift for life (paper edition, Spanish translation) | This is the first print of the WMDA Handbook for registries; it has been replaced by an online English edition | Out of date | 3.04, 3.05, 3.06, 3.09, 3.10.1, 3.11, 3.11.1, 3.13, 3.15 | Informed consent--suggested procedures for informed consent for unrelated haematopoietic stem cell donors at various stages of recruitment, donor evaluation, and donor workup. Bone Marrow Transplantation (2003) 31: 539-545 | This is a checklist to set up an informed consent at the various stages. The paper has been replaced by the WMDA Guidance to explain the WMDA Standards. The guidance can be found at:https://share.wmda.info/x/0wB7Cw| by an online English edition (online WMDA Handbook). | Out of date | | 10.11 | Donor and liability of donor registries, donor centres and collection centres-recommendations Bone Marrow Transplantation (2004), 33: 467-470 | The paper outlines the ethical aspects of liability of involved parties and the need for insurance coverage. The article has shortcoming with the respect to legal advices. | Out of date | 3.04, 3.05, 3.06, 3.09, 3.10.1, 3.11, 3.11.1, 3.13, 3.15 | Informed consent--suggested procedures for informed consent for unrelated haematopoietic stem cell donors at various stages of recruitment, donor evaluation, and donor workup. Bone Marrow Transplantation (2003) 31: 539-545 | This is a checklist on informed consent at the various stages. The paper has been replaced by the WMDA guidance to explain the WMDA Standards. The guidance can be found at:https://share.wmda.info/x/0wB7Cw | Out of date | 3.20 4.16 | A special report: histocompatibility testing guidelines for hematopoietic stem cell transplantation using volunteer donors. Histocompatibility testing guidelines for hematopoietic stem cell transplantation using volunteer donors: report from The World Marrow Donor Association
A special report: histocompatibility testing guidelines for hematopoietic stem cell transplantation using volunteer donors | This publication is now outdated. It provided recommendations on the HLA typing of donors. | Out of date |
| Standards, regulations and accreditation for registries involved in the worldwide exchange of hematopoietic stem cell donors and products. Bone Marrow Transplantation (2010), 45:819-824 | WMDA has developed online documentation to explain the accreditation process, which is available at WMDA Share under the pillar: 'Ensuring Quality' | Out of date |
| International exchange of cord blood units; the registry aspects Bone Marrow Transplantation (2010), 45: 825-831 | Replaced by chapter 6 of the WMDA |
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handbook a gift life has been a more reassuring an updated statement. The recommendation |
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has been has been is visible to inventorize is of | for DNA typings. The paper |
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has been DNA typings has been DNA typings has been of | in the search for international unrelated donors. The paper has been replaced by the WMDA Handbook: A |
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