General Organisation of a Registry
Recruitment and evaluation of volunteer donors| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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| 2.08 | Quality | 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 (2020) | | 3.02 | Global Development | Qualifications and training of adult stem cell donor recruiters: recommendations by the World Marrow Donor Association Bone Marrow Transplantation (2013) 48: 1480150 | This paper provides recommendations regarding qualifications and training of recruiters. Online recruitment is not described in this paper. | Update required. | | 3.03, 3.04, 3.09, 6.07, 6.07.1, 3.24, 10.11, 10.13 | Donor Care | Donor safety: the role of the WMDA in ensuring the safety of volunteer unrelated donors: clinical and ethical considerations. 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 (2017) | 3.13 4.09 | 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 3.22.1 | Donor Care | 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 second publication 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 (2020)
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Donor search request| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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2.07 | Global Development | Recommendation on the training of staff performing patient donor search and HLA matching activities Responsibilities of registry search coordinators | Recommendations by WMDA accredited registries on education of registry staff. Survey was performed in 2009. | Update review, contact Irina Evseeva | | 7.01 | Donor Care | WMDA Guidelines for subsequent donations following initial BM or PBSCs Bone Marrow Transplantation (2011) 46: 1409-1412 | This guideline is intended to outline where subsequent donations would routinely be considered appropriate (from the donor's point-of-view), as well as the frequency and timing of such donations. The background is outdated, the recommendations are current, the data are outdated and the survey information is outdated. | Under review, see https://share.wmda.info/x/8qWbEw for more information | | 3.03, 3.06, 6.06 | Donor Care | Donor commitment and patient needs Bone Marrow Transplantation (2004) 33: 225-230 | This paper describes ethical issues related to the donation of hematopoietic stem cell products with respect to recruitment, evaluation, workup, and follow-up of unrelated donors. | Current (2017) |
| 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 (2018) |
Collection and transportation| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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8.05 | Donor Care | Recommendation for recombinant human G-CSF (G-CSF) that stem cell registries can use - the use of biosimilar G-CSF | WMDA recommendation on the use of biosimilar filgrastims. | Current (2018) | | 8.05 | Donor Care | Current use of biosimilar G-CSF for haematopoietic stem cell mobilisation
Bone Marrow Transplantation (2019): 54, 858-866
| WMDA recommends that stem cell donor registries can use filgrastim biosimilars for the mobilisation of peripheral blood progenitor cells in healthy donors, provided that they are approved by national and/or regional agencies. | Current (2019) | | 3.03 | Donor Care | Remuneration of hematopoietic stem cell donors: principles and perspective of the World Marrow Donor Association. Blood (2010) 117: 21-25 | This paper describes the reasons that the WMDA continues to believe that donors should not be paid due to ethical concerns raised by remuneration, potential to damage the public will to act altruistically, the potential for coercion and exploitation of donors, increased risk to patients, harm to local transplantation programs and international stem cell exchange, and the possibility of benefiting some patients while disadvantaging others. | Current (2017) | | 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: 244â257 | 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 (2020) | | 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 revision. Paper is from 2010. Susie Joron | | 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 (2021) | | 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) |
Post-donationCord blood banking| WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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5.04.1 | Search, Match & Connect | Global Registration Identifier for Donors (GRID) of Hematopoietic Stem Cells: Road to Automation and Safety Transfusion Medicine and Hemotherapy (2017), 44: 407-413 | An educational paper to explain why GRID is implemented on a global scale. | Current (2018) | | 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 (2018) | | 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, MĂŒller 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 âmultiple allele codesâ have been added. | Current (2017) | | 5.02 | Search, Match & Connect | 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 document provides the 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) | 5.15.2 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 (2020) | 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 (2020) | 5.15.2 5.16 | Search, Match & Connect | Technical documentation | The purpose of this document is to provide standards and guidance for the coding and labeling of medical products of human origin (MPHO): blood, cellular therapy, tissues, 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 (2020) | | 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 (2017) |
| 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 (2017) | | 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. | Current (2017) |
Publications in partnership with other professional societies | WMDA Standard | Responsible Pillar | Title and link to document | Explanation | Status |
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| Foundation | Position paper on Unproven Cell-Based Therapies: Current Global Status and Recommendations to the World Health Organization (not yet publicly available, to be added after approval of WBMT) | 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. | Current (2020) | | 8.07 | Quality | Circular of Information for the Use of Cellular Therapy Products
PDF document | 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 (2021) |
| 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: 778â785 | Paper outlining the transplant activity from 2006 till 2012. | Current (2017) | 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. | Current (2017) | 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. | Current (2017) |
| 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. | Current (2018) | | 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. | Current (2017) |
| Global Development | "Worldwide Network for Blood & Marrow Transplantation (WBMT) special article, challenges facing emerging alternate donor registriesâ Bone Marrow Transplantation (2019) | Paper outlining the challenges for emerging donor registrries | Current (2019) |
| 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. |
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Archived Publications| WMDA Standard | Title and link to document | Explanation | Status |
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| 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 donaciĂłn de cĂ©lulas madre sanguĂneas | 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 | 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 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 | Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilisation of stem cells in normal donors: position of World Marrow Donor Association. 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 | A review of the genetic and long-term effects of G-CSF injections in healthy donors: a reassuring lack of evidence for the development of haematological malignancies 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 | Haematopoietic stem cell donor registries: World Marrow Donor Association recommendations for evaluation of donor health. 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. The paper was updated in 2014. | Out of date |
| World Marrow Donor Association: international standards for unrelated hematopoietic stem cell donor registries 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 | 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. Bochtler W, Maiers M, Oudshoorn M, Marsh SG, Raffoux C, Mueller C, Hurley CK. 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 |
| HLA dictionary 2004: summary of HLA-A, -B, -C, -DRB1/3/4/5, -DQB1 alleles and their association with serologically defined HLA-A, -B, -C, -DR, and -DQ antigens. 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 |
| The HLA Dictionary 2001: a summary of HLAâA, âB, âC, âDRB1/3/4/5 and âDQB1 alleles and their association with serologically defined HLAâA, âB, âC, âDR and âDQ antigens 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. |
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| The HLA dictionary 1999: a summary of HLA-A, -B, -C, -DRB1/3/4/5, -DQB1 alleles and their association with serologically defined HLA-A, -B, -C, -DR, and -DQ antigens. 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 |
| The search for HLA-matched donors: a summary of HLA-A*, -B*, -DRB1/3/4/5* alleles and their association with serologically defined HLA-A, -B, -DR antigens. 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 |
| A special report: suggested procedures for international unrelated donor search from the donor registries and quality assurance working groups of the World Marrow Donor Association (WMDA). 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 |
| Donor work-up and transport of bone marrow--recommendations and requirements for a standardized practice throughout the world from the Donor Registries and Quality Assurance Working Groups of the World Marrow Donor Association (WMDA). Bone Marrow Transplantation (1997) 20: 621â629 | One of the first WMDA publications describing donor work-up. More current information can be found in the WMDA handbook. | Out of date |
| A special report: bone marrow transplants using volunteer donors-- recommendations and requirements for a standardized practice throughout the world--1994 update. The WMDA Executive Committee Blood (1994) 84: 2833-2389 | This paper amplifies the previous publication and gives special attention to accreditation of national âhubsâ (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 transplants using volunteer donors--recommendations and requirements for a standardized practice throughout the world. The Executive Committee of the World Marrow Donor Association. Bone Marrow Transplantation (1992) 10: 287-291 | Historical paper of WMDA, the first publication, outlining the hub concept. | Out of date |
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