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This webpage is based on the chapters of the WMDAPUBHB with the title 'A Gift for Life'

More information about the WMDA handbook:

Table of contents

WMDA Scientific Publications and Recommendations by subject

General Organisation of a Registry

WMDA StandardTitle and link to documentExplanationStatus
1.03Global Trends Report of WMDAAnnual publication presenting the unrelated stem cell donor activity on a global scale.Current (2019)
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.

Under review (2020)

2.10

2.10.1

WMDA Quality ManualA template for a quality manual for registries and cord blood banks.

Current

(2020)

2.10.2

World marrow donor association crisis response, business continuity, and disaster recovery guidelines.

Biology of Blood and Marrow Transplantation (2012) 18: 1785-1789

This paper cover the minimal requirements of preparedness in prevention and mitigation, crisis response, business continuity, and disaster recovery, and the need for continued maintenance and revision. Issues of international cooperation are addressed as well.

Visit as well the following webpage: https://share.wmda.info/x/dQAOEw

Current (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)
1.07Criteria 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:

  • TC is accredited by FACT-JACIE
  • TC is affiliated with a WMDA qualified or accredited organisation
Current (2020)


Recruitment and evaluation of volunteer donors

WMDA StandardTitle and link to documentExplanationStatus
2.08Key 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

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 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

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

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)



Donor search request

WMDA StandardTitle and link to documentExplanationStatus
1.06Donor centre auditCreate 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

Irina Evseeva

7.01

WMDA Guidelines for subsequent donations following initial BM or PBSCs

Bone Marrow Transplantation (2011) 46: 1409-1412

This guideline is intended to outline where subsequent donations would routinely be considered appropriate (from the donor's point-of-view), as well as the frequency and timing of such donations. The background is outdated, the recommendations are current, the data are outdated and the survey information is outdated.

Under review, see https://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 FormsForms for each step in the search processCurrent (2018)

Responsibilities of registry search coordinators
Current (2019)

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 StandardTitle and link todocumentExplanationStatus

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.Current (2018)
8.05

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

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

Audits of collection and apheresis centers: guidelines by the World Marrow Donor Association Working Group Quality and Regulation

Bone Marrow Transplantation (2018) 54: 244–257

This paper describes the general requirements and recommendations for collaboration with the collection and apheresis centers and defines critical procedures for the collection of the stem cell product, such as the information session, medical assessment, product collection, quality controls, product handover for transportation, and donor follow-up. The specific guidelines are accompanied by detailed checklists and forms that can be found in Supplementary Information and may be used during an initial or follow-up on-site or paper-based audit. For more information you can visit: https://share.wmda.info/x/OAKQEQCurrent (2020)
8.07.1

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

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.Current (2017)
8.08Validation of Product Transportation ContainersThis report provides WMDA guidelines for validation of transport containers used for the distribution of HSC productsCurrent (2018)


Post-donation

WMDA StandardTitle and link todocumentExplanationStatus

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

Towards a global system of vigilance and surveillance in unrelated donors of haematopoietic progenitor cells for transplantation.

Bone Marrow Transplantation (2013) 48: 1506-1509

This paper describes WMDA's implementation of an international reporting system for serious adverse events and reactions.Current (2018)

Cord blood banking

WMDA StandardTitle and link todocumentExplanationStatus

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 bankingCurrent (2019)
4.26Recommendation for use of cord blood samples by cord blood banks and transplant centresDiscussion for cord blood banks on how to handle reservation requests for attached segmentsUnder review (2018)

Information technology and data management

WMDA StandardTitle and link todocumentExplanationStatus

5.04.1

Global Registration Identifier for Donors (GRID) of Hematopoietic Stem Cells: Road to Automation and Safety

Transfusion Medicine and Hemotherapy (2017), 44: 407-413

An educational paper to explain why GRID is implemented on a global scale.Current (2018)
5.04.1GRID: Moving to Unique Donor IdentifierA public webpage with educational materials to implement GRID in a registry.Current (2018)
5.02

An update to the HLA Nomenclature Guidelines of the World Marrow Donor Association, 2012 Bochtler W, Maiers M, Bakker JN, Baier DM, Hofmann JA, Pingel J, Rist HG, Oudshoorn M, Marsh SG, Müller CR, Hurley CK; Information Technology Working Group of the World Marrow Donor Association.

Bone Marrow Transplantation (2013) 48: 1387-1388

An update of the paper published in 2007. The update became necessary after the major revision of the WHO HLA nomenclature in April 2010. It now covers issues arising when alleles are withdrawn or renamed because of the continuous updating of the WHO HLA nomenclature. In addition, formal validation and interpretation rules for the so-called ‘multiple allele codes’ have been added.Current (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 banksCurrent (2017)

5.15.2

5.16

GRID Implementation Plan - TemplateThis document provide a template developed by the GRID Task Force how to implement GRID in a registryCurrent (2020)

5.15.2

5.16

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

Technical documentationThe 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 relevantCurrent (2020)
5.17

World Marrow Donor Association framework for the implementation of HLA matching programs in hematopoietic stem cell donor registries and cord blood banks.

Bone Marrow Transplantation (2011) 46:338-343

This paper defines a comprehensive framework for HLA matching programs, which use intricate algorithms to rapidly select potential donors for a patient from a database and to present these donors in a prioritized list.Current (2017)

Information technology and the role of WMDA in promoting standards for international exchange of hematopoietic stem cell donors and products.

Bone Marrow Transplantation (2010) 45: 839-842

Overview paper of the activities in the area of information technology, described in 2010.

  • Standardized reference data sets for validation and plausibility controls for HLA and other data domains
  • Matching algorithm standards for determining histocompatibility
  • Communication standards between registries.
Current (2017)
5.02

A comparative reference study for the validation of HLA-matching algorithms in the search for allogeneic hematopoietic stem cell donors and cord blood units.

HLA Immune Responds Genetic (2016) 87: 439-448

A comparison of matching algorithms used different registries.Current (2017)

Publications in partnership with other professional societies

WMDA StandardTitle and link to documentExplanationStatus

Position paper on Unproven Cell-Based Therapies: Current Global Status and Recommendations to the World Health OrganizationDirect-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)
8.07Circular 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. 

The Task Force intentionally limited its scope to only include minimally manipulated cellular therapy products such as peripheral blood progenitor cells, bone marrow, cord bloodand leukocytes. The group recognizes there are multiple cellular therapy products that could not be adequately covered in the Circular. To accommodate this, the Circular includes multiple blank pages at the end of the document to allow for the addition of productorfacility specific information.

Current (2018)

Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey.

Bone Marrow Transplantation (2016) 51: 778–785

Paper outlining the transplant activity from 2006 till 2012.Current (2017)

9.02

Allogeneic hematopoietic stem cell donation-standardized assessment of donor outcome data: a consensus statement from the Worldwide Network for Blood and Marrow Transplantation (WBMT).

Bone Marrow Transplantation (2012) 48: 220-225

Global consensus document to perform long-term follow up on donors asses the impact of novel agents given to donors.Current (2017)

3.22

3.22.3

Suitability Criteria for Adult Related Donors: A Consensus Statement from the Worldwide Network for Blood and Marrow Transplantation Standing Committee on Donor Issues.

Biology of Blood and Marrow Transplantation (2015) 21: 2052-2060

Global consensus document with recommendations for donor workup and final clearance of family donors who would not be able to serve as unrelated donors because of their age or pre-existing diseases. This article covers different topics intending to support decision-making, with the goal of minimizing medical risk to the donor and protection of the recipient from transmissible diseases.Current (2017)

Definitions of histocompatibility typing terms

Blood (2011) 118: 180-183


Definitions of histocompatibility typing terms: Harmonization of 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)

"Worldwide Network for Blood & Marrow Transplantation (WBMT) special article, challenges facing emerging alternate donor registries”

Bone Marrow Transplantation (2019)

Paper outlining the challenges for emerging donor registrriesCurrent (2019)



Archived Publications

WMDA StandardTitle and link todocumentExplanationStatus

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 sanguíneasThis 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/0wB7CwOut 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 LifeOut 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/bmt201393Out 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 HLA‐A, ‐B, ‐C, ‐DRB1/3/4/5 and ‐DQB1 alleles and their association with serologically defined HLA‐A, ‐B, ‐C, ‐DR and ‐DQ 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.



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: 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

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 “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