General Organisation of a Registry
| WMDA Standard | Title and link to document | Explanation | Status |
|---|---|---|---|
| 1.03 | Global Trends Report of WMDA | Annual publication presenting the unrelated stem cell donor activity on a global scale. | Current (2020) |
| 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. | |
2.10 2.10.1 | 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 | Current(2020) Current (2020) |
2.10.2 | 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 (2020) |
| Related donors | 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 (2017) |
| Related donors | 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) |
| 1.07 | Criteria for Evaluation of Transplant Centres | Develop criteria and a form to evaluate transplant centres (TC) in the following situations:
TC does not need toevaluatedif the following apply:
| Current (2020) |
Recruitment and evaluation of volunteer donors
| WMDA Standard | Title and link to document | Explanation | Status |
|---|---|---|---|
| 2.08 | 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 (2019) |
| 3.02 | 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 | 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 | 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 | 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) |
Donor search request
| WMDA Standard | Title and link to document | Explanation | Status |
|---|---|---|---|
| 1.06 | Donor centre audit | Create guidelines and checklists to audit donor centres. | Under development |
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. | Update review, contact |
| 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://share.wmda.info/x/8qWbEw for 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) | |
| Responsibilities of registry search coordinators | Current (2019) | ||
| 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 | Title and link todocument | Explanation | Status |
|---|---|---|---|
8.05 | WMDA recommendation on the use of biosimilar filgrastims. | Current (2018) | |
| 8.05 | Current use of biosimilar G-CSF for haematopoietic stem cell mobilisation | 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 | 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 | 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. For more information you can visit: https://share.wmda.info/x/OAKQEQ | Current (2020) |
| 8.07.1 | Introduction and Importance of a Globally Unique Identity and Labelling Format (ISBT-128) | 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. |
| 8.08 | The paper describes recommendations for couriers and the transportation of haematopoietic progenitor cells. | Current (2017) | |
| 8.08 | 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-donation
| WMDA Standard | Title and link todocument | Explanation | Status |
|---|---|---|---|
9.03, 9.04 | 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 (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 | Bone Marrow Transplantation (2013) 48: 1506-1509 | This paper describes WMDA's implementation of an international reporting system for serious adverse events and reactions. | Current (2018) |
Cord blood banking
| WMDA Standard | Title and link todocument | Explanation | Status |
|---|---|---|---|
4.03, 4.04, 4.05, 4.06 | 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 | WMDA Policy Statement on the Utility of Autologous or Family Cord Blood Unit Storage | WMDA policy statement on private cord blood banking | Current (2019) |
| 4.26 | 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) |
Information technology and data management
| WMDA Standard | Title and link todocument | Explanation | Status |
|---|---|---|---|
5.04.1 | 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) |
| 5.02 | 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 (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 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 | 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 | Global Registration Identifier for Donors: ION database and GRID rules | The purpose of this document is to provide:
| Current (2020) |
5.15.2 5.16 | 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 | 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) |
Bone Marrow Transplantation (2010) 45: 839-842 | Overview paper of the activities in the area of information technology, described in 2010.
| Current (2017) | |
| 5.02 | 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 | Title and link to document | Explanation | Status |
|---|---|---|---|
| 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 | Circular of Information for the Use of Cellular Therapy Products | The circular 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 includes a collaborativegroup 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. | Current (2018) |
Bone Marrow Transplantation (2016) 51: 778–785 | Paper outlining the transplant activity from 2006 till 2012. | Current (2017) | |
9.02 | 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 | 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 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 | 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) |
Bone Marrow Transplantation (2019) | 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 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 | |
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 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 |