General Organisation of a Registry
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
1.03: A registry that intends to request WMDA certification (Benchmark Level 1/2) or that has obtained WMDA certification (Benchmark Level 1/2 or WMDA Full Standards compliance) must participate in the annual WMDA Global Trends Report. | Global Development | Global Trends Report of WMDA | Annual publication presenting the unrelated stem cell donor activity on a global scale. | Current (2025) |
| 1.06: The registry's policy must describe how the providing registry determines that a donor centre(s) or cord blood bank(s) under its oversight complies with WMDA Standards to recruit and characterise donors/umbilical cord blood units. The duties and responsibilities of the registry and donor centre(s)/cord blood bank(s) and the nature of the oversight must be documented. | Global Development | Bone Marrow Transplantation (2022) 57:466–472 | Guidelines on how to review a donor centre including a checklist | Current (2024) |
| 1.06: The registry's policy must describe how the providing registry determines that a donor centre(s) or cord blood bank(s) under its oversight complies with WMDA Standards to recruit and characterise donors/umbilical cord blood units. The duties and responsibilities of the registry and donor centre(s)/cord blood bank(s) and the nature of the oversight must be documented. | Quality | WMDA Guidance for Addition of New Affiliated Entity to a Registry | 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 to eliminate that risk. | Current (2024) |
| 1.06: The registry's policy must describe how the providing registry determines that a donor centre(s) or cord blood bank(s) under its oversight complies with WMDA Standards to recruit and characterise donors/umbilical cord blood units. The duties and responsibilities of the registry and donor centre(s)/cord blood bank(s) and the nature of the oversight must be documented. | Quality | 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. | Current (2024) | |
| 1.07: The registry must ensure that transplant centres under its oversight comply with relevant WMDA Standards when requesting a haematopoietic stem cell product from another country. The duties and responsibilities of the requesting registry and transplant centre(s) and the nature of the oversight must be documented. | Global Development | CONDITIONS for EVALUATION A Transplant Center does not need to be evaluated for WMDA Search & Match Service access if the following apply:
The WMDA criteria may be used by a registry to evaluate a TC under one or more of the following situations:
MATERIALS FOR WMDA CRITERIA and EVALUATION OF TRANSPLANT CENTERS
| Under review (2024) | |
| 2.08: The registry must retain a staff large enough to assume the volume and variety of services required to perform international searches within a timeframe in accordance with WMDA metrics for the unrelated donor search process while maintaining the confidentiality of patient and donor. | Global Development | WMDA has defined 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 (2024) | |
2.10: The registry must have a system of quality management to assess, ensure, conduct and improve the quality of its operations. | Global Development | A template for a quality manual for registries and cord blood banks. | Under review (2024) | |
2.10.1: The registry must maintain documented policies and procedures for all processes performed in the registry. This must include manual of operations, standard operating procedures, and forms. | Global Development | Notification and request for information regarding problems between registries | A template for registry to registry problem management communication. Notification and request for information regarding a problem arising | Current (2025) |
2.10.1: The registry must maintain documented policies and procedures for all processes performed in the registry. This must include manual of operations, standard operating procedures, and forms. | 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 (2025) |
2.10.2: The registry should have a plan to provide crisis response, business continuity and disaster recovery. | Global Development | 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) |
Recruitment and Evaluation of Volunteer Donors
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
| 3.02: Recruitment of donors must be performed by professionals trained for recruitment, under the direction of individuals who are experienced in recruitment of donors and in management activities including education, consenting, counselling, confidentiality, and medical screening. These individuals must be appropriately qualified and provided with timely and relevant training. The training and experience of these individuals must be documented. | Global Development | Bone Marrow Transplantation (2013) 48: 148-150 | This paper provides recommendations regarding qualifications and training of recruiters. Online recruitment is not described in this paper. | Under review -Donor Recruitment & Donor Retention Committee |
3.03: The willingness to become a donor must be the individual choice of each donor, that is, donations must be voluntary. Donors must be willing to donate on behalf of any patient being treated in any part of the world. Donors must not be paid for their donation and may be reimbursed for expenses incurred during the donation process. 3.04: Donors must be informed regarding their potential role in the donation of haematopoietic stem cells, the risks involved in the donation, and the tests that the donor may undergo. | Donor Care | Bone Marrow Transplantation (2010) 45: 832-838 | This paper provides information about the donor care standards of the WMDA. The paper was published in 2010, the wording of the WMDA Standards have changed over time. | Current (2021) |
3.13: Valid signed informed consent must be obtained if donor blood or other biological material or information is stored and/or used for the purpose of an ethically approved research project. | Donor Care | 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: Donor health requirements regarding the suitability of donors must be established. | Donor Care | Bone Marrow Transplantation 49:880-886 | The paper outlines the background of safety considerations for unrelated adult donors and recipients. It introduces a shared framework for evaluating donor health at every stage of the donation journey and presents a new way to share international consensus criteria on specific medical and lifestyle conditions. The links mentioned in the scientific article do not work anymore, find here the updated links: https://share.wmda.info/x/FABtEQ | Current (2021) |
3.22.1: An initial health screening should be performed at the time of recruitment. | Donor Care | Guidance for assessing the medical suitability for adult volunteer donors | The Share website captures the consensus of the WMDA Donor Medical Suitability Committee. Its goal is to establish globally harmonised medical assessment criteria that both safeguard donor well-being and ensure the safety and quality of cellular products worldwide. The links in the article do not work anymore, find here the updated links: https://share.wmda.info/x/FABtEQ | Current (2021) |
| Global Development / Search, Match & Connect | The RUN Project is an initiative aiming to identify and address inequity in access to transplant for patients with uncommon HLA genotypes, typically from populations who have been historically underrepresented and underserved by global donor inventories. While transplant professionals are generally aware of the gaps within their own countries, through working together as a community we can explore how to best target recruitment of identified ethnicities across diaspora to see how the global network can improve donor prospects for patients in need. | Current (2025) |
Facilitation of Search Requests
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
2.07:The registry staff must be trained and knowledgeable about their duties. The registry must conduct and document staff training and maintain training records. | Global Development | Recruitment, training, and ongoing educational requirements for donor registry search coordinators | Recommendations by WMDA certified registries on education of registry staff. Survey was performed in 2009. | Current (2024) |
| 6.06: The policy of the registry regarding repetition of the database search for a specific patient must be defined and readily accessible to the relevant health care professionals. | 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) |
| 3.22.3: Policies for testing the donor selected for workup must be established and must include medical history, physical examination, and laboratory tests in order to determine the donor’s fitness to donate. | Donor Care | Biology of Blood and Marrow Transplantation, Volume 24, Issue 5, 887 - 894 | This paper aims to clarify key ethical and procedural principles related to HPC donation, illustrated with real-life examples commonly encountered by donor registries (DR/DCs). Strengthening international collaboration and continuing education on these issues will support both registries and transplant centres in making balanced, transparent decisions—even when facing complex ethical challenges. | Current (2021) |
Collection and Transportation
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
8.05: If a donor is subjected to a medical intervention as part of the collection process, the registry must have policies and procedures to protect the health and safety of the donor and of the recipient. | Donor Care | P3DC.2501 WMDA Statement on Use of Biosimilar Mobilising Agents.pdf | This paper presents updated WMDA recommendations on the use of biosimilar recombinant human granulocyte colony-stimulating factor (G-CSF) for mobilising haematopoietic stem cells in healthy unrelated donors. The guidance is informed by a global survey and a comprehensive literature review, ensuring safe and effective use of biosimilar mobilising agents worldwide. The WMDA membership board reviewed the paper before approval by the CEO. | Current (2025) |
| 8.05: If a donor is subjected to a medical intervention as part of the collection process, the registry must have policies and procedures to protect the health and safety of the donor and of the recipient. | Donor Care | Current use of biosimilar G-CSF for haematopoietic stem cell mobilisation | This paper presents the WMDA recommendations 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 (2025) |
| 3.03: The willingness to become a donor must be the individual choice of each donor, that is, donations must be voluntary. Donors must be willing to donate on behalf of any patient being treated in any part of the world. Donors must not be paid for their donation and may be reimbursed for expenses incurred during the donation process. | Donor Care | 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: The registry's policy must describe how the providing registry determines that a collection centre(s) under its oversight complies with WMDA Standards for the collection of haematopoietic stem cells or other donor samples, for donor medical evaluation or for the follow-up of donors. The duties and responsibilities of the registry and collection centre(s) and the nature of the oversight must be documented. 8.01: Collection of haematopoietic stem cells and any other collected cells intended for cellular therapy, must be performed at a collection centre/cord blood collection site conforming to applicable regulation | Quality | 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) |
| 8.08: Critical transport conditions, such as temperature and time limit must be defined to maintain the required cell properties. | Quality | The paper describes recommendations for couriers and the transportation of haematopoietic progenitor cells. | Under review (2024) | |
| 8.08: Critical transport conditions, such as temperature and time limit must be defined to maintain the required cell properties. | 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) |
Follow-Up
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
9.03: Serious Adverse Events and Reactions affecting donors undergoing collection of HSC and/or cellular product, occurring both in the long term and/or the short term as a consequence of the donation, must be identified, documented, investigated and remedial and/or corrective action taken. The Serious Adverse Reactions must be submitted to the WMDA SPEAR Committee. 9.04: The registry must comply with applicable regulations including requirements to report such adverse reactions to a regulatory agency. | 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) |
Umbilical Cord Blood and Maternal Donor Recruitment
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
4.03: The willingness to donate cord blood must be the individual choice of each maternal donor, that is, donations must be voluntary. The maternal donor must be willing to donate to any patient being treated in any part of the world and must not be paid for their donation. | Global Development | Combined Private and Public Cord Blood Banking and Other Related Products | Guiding principles for cord blood banks that operate a public and private inventory | Current (2019) |
| 4.03: The willingness to donate cord blood must be the individual choice of each maternal donor, that is, donations must be voluntary. The maternal donor must be willing to donate to any patient being treated in any part of the world and must not be paid for their donation. | Global Development | WMDA Policy Statement on the Utility of Autologous or Family Cord Blood Unit Storage | WMDA policy statement on private cord blood banking | Current (2019) |
| The recruitment of maternal donors must be performed under the direction of individuals who are experienced in recruitment of maternal donors and in management activities including education, consenting, counselling, confidentiality, and medical screening. These individuals must be appropriately qualified and provided with timely and relevant training. The training and experience of these individuals must be documented. | Global Development | Family-directed Umbilical Cord Blood Banking Haematologica (2011) 96: 1700-1707 | Educational paper about the distinction of different types of cord blood banking. | Current (2017) |
| 4.26: Prior to shipment, the identity of the cord blood unit must be verified through verification typing from an attached segment of the cord blood unit or through any other validated procedure. | Global Development | Recommendation for use of cord blood samples by cord blood banks and transplant centres | Discussion for cord blood banks on how to handle reservation requests for attached segments | Under review (2018) |
Data Technology and Data Management
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
5.02: Electronic connection and communication between organisations must be coordinated and performed with greatest possible care minimising vulnerabilities and exploitation risks. | Search, Match & Connect | 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: In the event of termination of operations, the registry must ensure continued adherence to data protection and record retention standards. | Search, Match & Connect | 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) | |
5.15.2: The registry, or its designee, must assign a unique and anonymous identifier to each donor, each maternal donor and each cellular product to ensure confidentiality. This identifier must be used to track each donor and cord blood unit with their associated data and biological material and their participation in the donation process long-term. | Search, Match & Connect | Transfus Med Hemother. (2017), 44: 407-413 | To ensure unambiguous identification of growing numbers of hematopoietic stem cell donors worldwide, the GRID system was developed—building on standardized frameworks like ISBT 128 and SEC—requiring global collaboration, rapid information access, and effective communication among all donor-related organisations. | Current (2024) |
5.16: The registry listing donors must use GRID to issue donor identifiers. | Search, Match & Connect | A public webpage with educational materials about GRID. | Current (2024) | |
| 5.15.1: Any HLA-related information stored, presented or communicated by the registry must follow WMDA guidelines for the use of HLA nomenclature. | Search, Match & Connect | World Marrow Donor Association guidelines for the reporting of novel HLA alleles HLA 102: 62-64 | 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) |
| 5.15.1: Any HLA-related information stored, presented or communicated by the registry must follow WMDA guidelines for the use of HLA nomenclature. | Search, Match & Connect | An update to the HLA Nomenclature Guidelines of the World Marrow Donor Association, 2012 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: The registry, or its designee, must assign a unique and anonymous identifier to each donor, each maternal donor and each cellular product to ensure confidentiality. This identifier must be used to track each donor and cord blood unit with their associated data and biological material and their participation in the donation process long-term. | Search, Match & Connect | ISBT 128 Standard for Coding Medical Products of Human Origin Transfus Med Hemother. (2017) 44:386-390 | 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 reports must generate lists of suitably matched donors/cord blood units in a reasonable time frame. | Search, Match & Connect | 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 | Bone Marrow Transplantation (2010) 45: 839-842 | Overview paper of the activities in the area of information technology, described in 2010.
| Current (2023) | |
| 5.17: Search reports must generate lists of suitably matched donors/cord blood units in a reasonable time frame. | Search, Match & Connect | HLA (2016) 87: 439-448 | A comparison of matching algorithms used different registries. | Under review |
Subsequent Donations
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
| 7.01: The registry must have a policy regarding the process to be followed when a transplant centre requests a subsequent donation and the time frame for the process of approval. | 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 paper is currently under review by the Medical Committee. | Under Review (2024) |
Related Donors
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
| 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) | |
| 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) |
Cell & Gene Therapy
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
| Donor Care | Bone Marrow Transplant 59, 580–586 (2024) | The World Marrow Donor Association (WMDA) advocates for non-remunerated allogeneic donation in the rapidly evolving cell and gene therapy (CGT) field, ensuring donor safety, ethical integrity, and equitable patient access to high-quality treatments. | ||
| Donor Care | The Cell and Gene Therapy (CGT) committee has created guidance documentation (incl. 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 | |||
| 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. |
SPEAR Communication
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
| Donor Care | 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 | Transplantation and Cellular Therapy, Volume 30, Issue 2,2024, Pages 143-154, ISSN 2666-6367 | 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) | |
| 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.
| Current (2024) | |
| 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. | Current (2024) | |
| Donor Care | 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. | Current (2024) | ||
| 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. | Current (2024) | |
| 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. | Current (2024) | |
| 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 (2025) |
Publications in Partnership with Other Professional Societies
| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
|---|---|---|---|---|
| 3.22: Donor health requirements regarding the suitability of donors must be established. | Donor Care | The Lancet Haematology, Volume 9, Issue 8, e605 - e614 | Related donors play an increasingly important role in the growing number of allogeneic haematopoietic stem cell transplants (HSCT), especially with the wider use of haploidentical HSCT. Unlike unrelated donor guidelines, criteria for related donors allow more flexibility and vary across transplant centres. In 2015, the Donor Outcome Committee of the Worldwide Network for Blood and Marrow Transplantation (WBMT) published consensus recommendations for the suitability of paediatric and adult related donors. This updated Review, developed by an international panel of experts—including WBMT, EBMT, CIBMTR, NMDP, and WMDA—builds on that work by reviewing the latest literature and guidelines. New and revised sections address:
The aim of these updates is to support transparent decision-making, minimise risks for related donors, and protect transplant recipients from transmissible diseases. | NA |
| 1.07: The registry must ensure that transplant centres under its oversight comply with relevant WMDA Standards when requesting a haematopoietic stem cell product from another country. The duties and responsibilities of the requesting registry and transplant centre(s) and the nature of the oversight must be documented. | Foundation | Position paper on Unproven Cell-Based Therapies: Current Global Status and Recommendations to the World Health Organization | The direct-to-consumer marketing of unproven cell-based interventions has become a growing global public health concern. These interventions generally fall into two categories: immune cell therapies (such as unmodified or gene-modified natural killer T-cells) and stem cell-based therapies. At present, only a limited number of these products have market authorisation, and the current scientific evidence does not support their use outside of carefully designed, strictly regulated clinical research studies. | NA |
| 8.07: Documentation of the characteristics of the collected product important in facilitating transplantation must be provided with the cells according to applicable guidelines. The documentation and/or label, at a minimum, must include information on the name of the product and product code, the number of cells collected, the donor’s unique identifier, donor ABO/Rh group, identification of the patient, date, and time of collection, any processing details, and name and contact information of the transplant centre. | Quality | Circular of Information for the Use of Cellular Therapy Products | The Circular of Information (Circular) serves as an extension of the label for cellular therapy products. It was developed by the AABB Circular of Information Task Force, a collaborative effort involving multiple nongovernmental organisations representing the cellular therapy field, with input from the US Food and Drug Administration (FDA) and the Health Resources and Service Administration (HRSA). The Circular focuses specifically on minimally manipulated cellular therapy products—including peripheral blood progenitor cells, bone marrow, cord blood, and leukocytes. Since not all cellular therapy products could be comprehensively addressed, the document also provides blank pages at the end, enabling facilities to add product- or site-specific information as needed. | (Current 2025) |
| NA | Foundation | Bone Marrow Transplantation (2016) 51: 778–785 | In 2012, data from 68,146 hematopoietic stem cell transplants (HSCTs) across 77 countries showed continued global growth, with more unrelated than related donor transplants and grafts mainly from peripheral blood, followed by bone marrow and cord blood. Compared to 2006, HSCTs increased by 46%—driven especially by allogeneic and mismatched/haploidentical family transplants—highlighting steady worldwide expansion without signs of plateauing. | NA |
9.02: The registry must have policies and procedures for the long-term follow-up and care of donors for conditions related to the HSC donation, including a mechanism for donors to contact the registry to report related medical concerns for a minimum of ten (10) years after donation. | Donor Care | Bone Marrow Transplantation (2012) 48: 220-225 | Global increases in allogeneic stem cell transplants highlight the urgent need for standardized international donor follow-up to ensure short- and long-term donor safety, improve data on risks, and guide future donor care. | NA |
3.22: Donor health requirements regarding the suitability of donors must be established. | Donor Care | Biology of Blood and Marrow Transplantation (2015) 21: 2052-2060 | As allogeneic stem cell transplants continue to rise, international experts have developed consensus recommendations to guide the assessment and clearance of related donors—especially those who may not meet unrelated donor criteria—aiming to protect both donor safety and recipient health. | NA |
| 5.17: Search reports must generate lists of suitably matched donors/cord blood units in a reasonable time frame. | 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: The recruitment of maternal donors must be performed under the direction of individuals who are experienced in recruitment of maternal donors and in management activities including education, consenting, counselling, confidentiality, and medical screening. These individuals must be appropriately qualified and provided with timely and relevant training. The training and experience of these individuals must be documented. | Global Development | Family-directed Umbilical Cord Blood Banking Haematologica (2011) 96: 1700-1707 | Educational paper about the distinction of different types of cord blood banking. | NA |
| NA | Global Development | Bone Marrow Transplant. 2019 Aug;54(8):1179-1188 | With over 50,000 allogeneic transplants performed annually worldwide, establishing and sustaining effective HCT donor registries requires careful planning to address financial, technical, ethnic, and geopolitical challenges while balancing costs with emerging alternatives like cord blood and haploidentical transplants. | NA |
Archived Publications
| WMDA Standard | Title and link to document | 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 of biosimilar filgrastims, replaced by an updated statement in 2025. | Out of date |
2.07 | Recommendation on the training of staff performing patient donor search and HLA matching activities | Recommendations by WMDA accredited registries on education of registry staff. Survey was performed in 2009. | Out of date |
| A gift for life (paper edition) | This is the first print of the WMDA Handbook for registries; it has been replaced by an online edition (online WMDA Handbook). | Out of date | |
| A gift for life (paper edition, Spanish translation) - un regalo para la vida - WMDA manual para la donación de células madre sanguíneas | This is the first print of the WMDA Handbook for registries; it has been replaced 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 | 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 | This publication is now outdated. It provided recommendations on the HLA typing of donors. | Out of date | |
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 Handbook: A Gift of Life | Out of date | |
| 1.03 | Monitoring the international use of unrelated donors for transplantation: the WMDA annual reports. Bone Marrow Transplantation (2010) 45: 811-818 | This report describes the trends throughout the 12 years that data have been collected and the results of the WMDA Annual Reports 2008, summarizing the activity as of 1 January 2009. The paper is updated annually by the Global Trends Report, see following link: https://share.wmda.info/x/whhcAQ | |
| 8.05 | Haematologica (2011): 96:942-943 | The aim of this paper is to review the basis of regulatory approval of the biosimilar G-CSF agents, including the available safety data, with reference to the indication for mobilization of PBSC in normal donors and to make recommendations based on these. The recommendation was updated in 2017. | Out of date |
3.22 3.22.2 | Bone Marrow Transplantation (2015) 50: 334-340 | This paper is an update from the statement issued by WMDA in 2007. On the basis of an assessment of a continuing lack of evidence for an increased risk of malignancy in donors receiving G-CSF, the WMDA has re-issued an updated statement. The recommendation was updated in 2017. | Out of date |
3.22 3.22.2 | Bone Marrow Transplantation (2008) 42: 9-14 | This document describes criteria for permanent or temporary deferral, guidelines for risk evaluation of infectious disease, examples of conditions requiring assessment and questionnaires designed to elicit relevant information about a donor's medical history and general health. | Out of date |
Bone Marrow Transplantation (2004) 34: 103-110 | A paper describing the first publication of the WMDA Standards, the current version of the WMDA Standards can be found at: https://www.wmda.info/professionals/quality-and-accreditation/wmda-standards/ | Out of date | |
Overview of registries, HLA typing and diversity, and search algorithms Tissue Antigens (2007) 69: 3-5 | This paper is an inventory of the registries HLA typing methods and quality control used to evaluate the accuracy of typing results. | Out of date | |
| 5.02 | Bone Marrow Transplantation (2007) 39:737-741 | This paper was updated in 2012, find here the link to the updated publication: https://www.nature.com/articles/bmt201393 | Out of date |
International Journal of Immunogenetics (2005) 32:19-69 | The paper provides information on the serological equivalents for DNA typings. The paper was updated in 2009. It is recommended to visit the IMGT/HLA website for the most recent information. | Out of date | |
European Journal of Immunogenetics (2001) 28: 565-596 | The paper provides information on the serological equivalents of HLA alleles. The paper was updated in 2004. It is recommended to visit the IMGT/HLA website for the most recent information. | ||
Human Immunology (1999) 11: 1157-1181 | The paper provides information on the serological equivalents of HLA alleles. The paper was updated in 2001. It is recommended to visit the IMGT/HLA website for the most recent information. | Out of date | |
Tissue Antigens (1997) 50: 401-418 | The paper provides information on the serological equivalents of DNA typings. The paper has been updated in 2001. It is recommended to visit the IMGT/HLA website for the most recent information. | Out of date | |
Bone Marrow Transplantation (2004) 34: 97-101 | This paper described the procedures and responsibilities in the search for international unrelated donors. The paper has been replaced by the WMDA Handbook: A Gift for Life. | Out of date | |
| Haematopoietic Stem Cell Registries: WMDA definitions of a donor center (2004) | This paper has been replaced by the paper: "Qualifications and training of adult stem cell donor recruiters" | Out of date | |
Bone Marrow Transplantation (1997) 20: 621–629 | One of the first WMDA publications describing donor work-up. More current information can be found in the WMDA handbook. | Out of date | |
Blood (1994) 84: 2833-2389 | This paper amplifies the previous publication and gives special attention to accreditation of national “hubs” (defined as coordinating centers for each country) and donor, harvest, and transplant centers, details of the marrow harvest procedure, use of peripheral blood (PB) stem cells for allografting, and use of PB lymphoid cells for treatment of leukemia relapsing after BMT. Historical document where the WMDA Standards are presented. | Out of date | |
Bone Marrow Transplantation (1992) 10: 287-291 | Historical paper of WMDA, the first publication, outlining the hub concept. | Out of date | |
Bone Marrow Transplantation (2013) 48: 1506-1509 | This paper describes WMDA's implementation of an international reporting system for serious adverse events and reactions. The way the SPEAR Committee operates has changed. | Out of date |