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This webpage is based on the chapters of the WMDAPUBHB.
General Organisation of a Registry
WMDA Standard | Title and link todocument | Explanation | Status |
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1.03 | Global Trends Report of WMDA | Annual publication presenting the unrelated stem cell donor activity on a global scale | Current (2018) |
10.13 | 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 hasshortcomingwith the respect tolegaladvices. | |
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) |
2.11 2.11.1 | WMDA Quality Manual | A template quality manual for organisations that prepare for WMDA Qualification/Accreditation | Current (2017) |
Relateddonors | Family donor care management: principles and recommendations Bone Marrow Transplantation (2010) 45: 1269-1273 | This document hopes to encourage increased collaboration between those caring for related and unrelated donors, and build on the extensive work, which has already been undertaken in this field to homogenize care. | Current (2017) |
Relateddonors | Related hematopoietic cell donor care: is there a role for unrelated donor registries? Bone Marrow Transplantation (2015) 50: 637-641 | Paperoutliningways how to enhanceandhomogeniserelateddonor care and if registries can play a roleincounsellingrelateddonors and collecting their hematopoietic stem cells. | Current (2018) |
1.07 | Criteria for Evaluation of Transplant Centres | Develop criteria and a form to evaluate TCs in the following situations:
TC does not need toevaluatedif the following apply:
| Under development |
1.06 | Donor centre Audit | Create guidelines and checklists to audit donorcentres | Under development |
Recruitment of volunteer donors
WMDA Standard | Title and link todocument | Explanation | Status |
---|---|---|---|
3.13 4.09 | Unrelated hematopoietic stem cell donors as research subjects Bone Marrow Transplantation (2011), 46: 10-13 | Discusses various implications of participation of unrelated stem cell donors in research protocols. | Current (2017) |
3.22 3.22.2 | Bone Marrow Transplantation 49:880-886 Guidance for assessing the medical suitability for adult volunteer donors | The paper provides a background to unrelated adult donor and recipient safety, recommends a common framework for assessing the health of unrelated adult donors at each stage of the donation pathway and presents a novel mechanism for sharing international consensus criteria for individual medical and lifestyle conditions. The guidance below reflects the consensus opinion provided by the WMDA donor medical suitability committee. The purpose of this guidance is to provide globally harmonised medical assessment criteria which simultaneously protect the interest of donors whilst ensuring the safety of cellular products across international boundaries. | Current (2017) |
3.02 | Bone Marrow Transplantation (2013) 48: 1480150 | This paper is providing recommendations regarding qualifications and training of recruiters. At the moment,the onlinerecruitment is not described in this paper. | Update required. |
2.08 | Key Performance Indicators for Registries | WMDA has defined five Key Performance Indicators 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 (2018) |
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 is providing information about the donor care standards of the WMDA. The paper has been published in 2010, the wording of the WMDA Standards might have changed over time. | Current (2017) |
Current (2018) |
Donor search request
WMDA Standard | Title and link todocument | Explanation | Status |
---|---|---|---|
2.07 | Recommendation on the training of staff performing patient donor search and HLA matching activities | Recommendations by WMDA accredited registries oneducationof registry staff.Surveyis done in 2009. | Update review, contact |
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) |
Collection and transportation
WMDA Standard | Title and link todocument | Explanation | Status |
---|---|---|---|
8.05 | WMDA recommendation on the use ofbiosimilarfilgrastims | 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 (2018) |
3.03 | Blood (2010) 117: 21-25 | This paper describes the reasons that the WMDA continues to believe that HSC donors should not be paid due to ethical concerns raised by remuneration, potential to damage the public will to act altruistically, the potential for coercion and exploitation of donors, increased risk to patients, harm to local transplantation programs and international stem cell exchange, and the possibility of benefiting some patients while disadvantaging others. | Current (2017) |
1.08 | Bone Marrow Transplantation (2018) | This paper describes the general requirements and recommendations for collaboration with the collection and apheresis centers and define critical procedures for the collection of the stem cell product, such as information session, medical assessment, product collection, quality controls, product handover for transportation, and donor follow-up. The specific guidelines are accompanied by detailed checklists and forms that can be found in Supplementary Information and may be used during an initial or follow-up on-site or paper-based audit. For more information you can visit: https://share.wmda.info/x/OAKQEQ | Current (2018) |
8.07.1 | Introduction and Importance of a Globally Unique Identity and Labelling Format (ISBT-128) | 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 | Develop WMDA guidelines for validation of transport containers used for the distribution of HSC products | Current (2018) |
8.07 | Circular of Information for the Use of Cellular Therapy Products | The Circular of Information (Circular) for the Use of Cellular Therapy Products is intended to be an extension of the cellular therapy product label. It has been jointly prepared by the AABB Circular of Information Cellular Therapies Task Force, which includesacollaborativegroup of multiple nongovernmental organizations that represent the cellular therapy field. The US Food and Drug Administration and the Health Resources and Service Administration also participated in the development and review process. | 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 ofdetailedexamination of adverse donor events. | Current (2018) |
9.03, 9.04, 5.04.1 | Inadvertent completely HLA-mismatched allogeneic unrelated bone marrow transplant: lessons learned. Bone Marrow Transplantation (2016) 51: 1016-1018 | This paper describes a serious adverse event in which a patient was transplanted with stem cells from an incorrect donor due in large part to the inappropriate use of a supposedly unique donor identifier. | Current (2018) |
9.03, 9.04 | Bone Marrow Transplantation (2013) 48: 1506-1509 | This paper described that WMDA has successfully implemented a reporting system for serious adverse events and reactions. | Current (2018) |
Cord Blood Banking
WMDA Standard | Title and link todocument | Explanation | Status |
---|---|---|---|
Combined Private and Public Cord Blood Banking and Other Related Products | Guiding principles for cord blood banks that operate a public and private inventory | Under review (2018) | |
WMDA Policy Statement on the Utility of Autologous or Family Cord Blood Unit Storage | WMDA policy statement on private cord blood banking | Under review (2018) | |
Recommendation for use of cord blood samples by cord blood banks and transplant centres | Discussion paper for cord blood banks how to handle reservation requests for attached segments | Under review (2018) |
Information technology and data management
WMDA Standard | Title and link todocument | Explanation | Status |
---|---|---|---|
2.11.2 | 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 (2017) |
3.20 4.16 | Human Immunology (1999) 60: 347-360 Bone Marrow Transplantation 24: 119-121 Tissue Antigens (1999) 53: 394-406 | To provide recommendations on the HLA typing of donors. | Under revision |
5.02 | An update to the HLA Nomenclature Guidelines of the World Marrow Donor Association, 2012 Bone Marrow Transplantation (2013) 48: 1387-1388 | An update from the paper published in 2007. The update became necessary after the major revision of the WHO HLA nomenclature in April 2010. It now covers issues arising when alleles are withdrawn or renamed because of the continuous updating of the WHO HLA nomenclature. In addition, formal validation and interpretation rules for the so-called ‘multiple allele codes’ have been added. | Current (2017) |
5.02 | This supplemantory document provides the entire updated information originally found in the publication: World Marrow Donor Association guidelines for use of HLA nomenclature and its validation in the data exchange among hematopoietic stem cell donor registries and cord blood banks | Current (2017) | |
5.17 | 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 paper to make sure that the matching algorithms used are correct. | Current (2017) |
Finance and administration
WMDA Standard | Title and link todocument | Explanation | Status |
---|---|---|---|
Publications in partnership with other professional societies
WMDA Standard | Title and link todocument | Explanation | Status |
---|---|---|---|
Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. | Paper outlining the transplant activity from 2006 till 2012. | Current (2017) | |
9.02 | Bone Marrow Transplantation (2012) 48: 220-225 | Global consensus document to perform long-term follow up on donors till 10 years after donation. | Current (2017) |
3.22 3.22.3 | 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 Human Immunology (2011) 12: 1214-1216 | The papers define terms for HLA typing resolution, HLA matching, and a format for reporting HLA assignments. In addition, definitions of verification typing and extended typing were addressed. | Current (2018) | |
4.02 | Family-directed Umbilical Cord Blood Banking Haematologica (2001) 96: 1700-1707 | Educational paper about the distinction of different types of cord blood banking. | Current (2017) |
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 | Out of date | |
A gift for life (paper edition, Spanish translation) | This is the first print of the WMDA Handbook for registries; it has been replaced by an online English edition | Out of date | |
3.04, 3.05, 3.06, 3.09, 3.10.1, 3.11, 3.11.1, 3.13, 3.15 | Bone Marrow Transplantation (2003) 31: 539-545 | This is a checklist to set up an informed consent at the various stages. The paper has been replaced by the WMDA Guidance to explain the WMDA Standards. The guidance can be found at:https://share.wmda.info/x/0wB7Cw | 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 has been 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 a more reassuring statement. The recommendation has been 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 is visible 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 to inventorize 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 is 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 of DNA typings. The paper has been 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 DNA typings. The paper has been 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 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 | |
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 of 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 | 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. | 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 |