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Worldwide Network for Blood and Marrow Transplantation (WBMT) Progress Report January-December 2013 www.wbmt.org Headquarters: Laupenstrasse 37, Postfach 7951, CH 3001 Bern, Switzerland

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Page 1: Worldwide Network for Blood and Marrow Transplantation … · Worldwide Network for Blood and Marrow Transplantation (WBMT) Progress Report January-December 2013 Headquarters: Laupenstrasse

Worldwide Network for Blood and Marrow Transplantation

(WBMT)

Progress Report

January-December 2013

www.wbmt.org

Headquarters: Laupenstrasse 37, Postfach 7951, CH 3001 Bern, Switzerland

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TABLE OF CONTENTS

1.0 INTRODUCTION ........................................................................................................................ 1

1.1 Early Development ............................................................................................................... 1

1.2 Working Relationship with the World Health Organization (WHO) .................................... 2

2.0 COMMITTEE STRUCTURE ......................................................................................................... 3

2.1 Board .................................................................................................................................... 3

2.2 Executive Committee ........................................................................................................... 3

2.3 Standing Committees ........................................................................................................... 3

3.0 STANDING COMMITTEE ANNUAL REPORTS AND 2013 ACCOMPLISHMENTS ......................... 5

3.1 Donor Issues Committee ...................................................................................................... 5

3.2 Education and Dissemination Committee ........................................................................... 6

3.3 Graft Processing Committee ................................................................................................ 7

3.4 Transplant Center/Recipient Committee............................................................................. 8

3.5 Regulation and Accreditation Committee ........................................................................... 9

4.0 WBMT ACTIVITIES AND 2013 ACCOMPLISHMENTS ............................................................... 11

4.1 Annual Global Survey ......................................................................................................... 11

4.2 Scientific and Educational Conferences ............................................................................. 12

4.3 Collaboration with the WHO.............................................................................................. 14

4.4 Consensus and Guideline Initiatives .................................................................................. 15

4.5 Supporting Other HSCT Global Activities ........................................................................... 16

4.6 Website Development ....................................................................................................... 17

5.0 FUTURE AIMS ......................................................................................................................... 18

6.0 PUBLICATIONS AND ABSTRACTS HISTORY ............................................................................. 19

APPENDIX A: MEMBER SOCIETIES ................................................................................................ 20

APPENDIX B: COLLABORATIVE ACTIVITIES WITH THE WHO ........................................................ 23

APPENDIX C: EXECUTIVE COMMITTEE VOTING MEMBERS ......................................................... 27

APPENDIX D1: CENTER SITES THAT CONTRIBUTE DATA TO THE ACTIVITY SURVEY .................... 29

APPENDIX D2: COUNTRIES THAT HAVE CONTRIBUTED DATA ..................................................... 30

APPENDIX E: HISTORY OF BOARD MEETINGS .............................................................................. 33

APPENDIX F: INTERNATIONAL SCIENTIFIC SYMPOSIA HISTORY (2009-present) ......................... 35

APPENDIX G: PUBLICATIONS LIST ................................................................................................ 38

APPENDIX H: TERMS AND ABBREVIATIONS ................................................................................. 40

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1.0 INTRODUCTION

The Worldwide Network for Blood and Marrow Transplantation (WBMT) was formally created in 2009 after two years of discussions; there was consensus on Bylaws and an organizational structure with leaders from major hematopoietic stem cell transplantation (HSCT) and donor registries worldwide. With the interest and support of the World Health Organization (WHO), these leaders shared a mutual vision of combining efforts towards improving standardization in the global application of HSCT, cellular therapy and related fields as well as broadening the scope of data sharing. This “Federation of Societies” began with 17 international organizations now numbering 21, all with substantial interest in HSCT (Appendix A). The WBMT was incorpo-rated as a non-profit organization for educational, scientific, and philanthropic purposes under the laws of Switzerland with headquarters in Bern. There is no fee for Member Societies, and its funding support is solicited from external corporations. Description of the first six years of ef-forts can be found in previous Progress Reports available at www.wbmt.org as they describe how those proactive clinicians and researchers shaped the WBMT into a recognizable organiza-tion, its structure and charter, its early achievements, and its future aims and goals. This re-port, however, focuses on the accomplishments of the WBMT during the calendar year 2013.

Of substantial relevance to the field of transplantation globally, WBMT played a lead role in collating, analysing, cross checking and verifying that the one millionth hematopoietic stem cell transplant was likely performed somewhere in the world towards the end of 2012; WBMT be-gan 2013 by proudly announcing this important milestone (Section 4.6).

1.1 Early Development

The four founding Member Societies of the WBMT are the Asia-Pacific Blood and Marrow Transplantation Group (APBMT), Center for International Blood and Marrow Transplant Re-search (CIBMTR), European Blood and Marrow Transplantation Group (EBMT), and World Mar-row Donor Association (WMDA). Representatives were invited in 2007 to help identify goals, communicate them to all other societies with interest or stake in HSCT and related fields, and initiate serious planning. They recognized:

HSCT is a global endeavor.

There was an urgent need to coordinate the activities of the different societies active in this field.

An international organization could support and even impact thoughtful, local legislation with a global perspective.

During those early meetings, it was agreed that the WBMT required a unique organizational structure to fulfill its goal of coordinating HSCT, stem cell donor and cellular therapy work worldwide. It was also important that it not duplicate decades of successful efforts by other established organizations; the result was the “Federation of Societies” structure.

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1.2 Working Relationship with the World Health Organization (WHO)

The collaborative relationship with the World Health Organization (WHO) culminated in an invi-tation in 2012 to apply for Non-Government Organization (NGO) status; this application was reviewed and formally approved by the WHO Executive Committee in January 2013 and carries with it certain obligations affecting WBMT activities (Section 4.3).

As noted above, the WHO strongly supported these early collaborative and unifying efforts and representatives continue to attend meetings as “observers”, assist in planning activities, and participate as forum presenters on a variety of relevant topics. Since acquiring NGO status, WBMT is obliged to provide a set of deliverables to the WHO in constant pursuit of its educa-tional, scientific, and philanthropic mission; see Section 4.3 and Appendix B.

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2.0 COMMITTEE STRUCTURE

2.1 Board

The Board is the highest tier of decision making for all WBMT activities. The WBMT Board in-cludes elected Executive Committee officials (President, Vice-President, Secretary/Treasurer and President-elect and/or Immediate Past President) as well as a Primary and Alternate repre-sentative from each of the twenty-one Member Societies. Each Member Society is permitted a single vote, either by the Primary or the Alternate representative. Non-voting members of the Board include co-Chairs of the Standing Committees (see below).

The Board meets annually in person (alternating between the winter BMT Tandem Meetings in the U.S. and the spring EBMT meetings in Europe) and holds two teleconferences, in summer and late fall, to handle issues between the in-person sessions. Meeting minutes are available on the password-protected section of the website (www.wbmt.org).

2.2 Executive Committee

The Executive Committee advises the Board and manages all business matters between Board meetings. Membership includes the elected President, Vice-President, Treasurer/Secretariat, and President-Elect and/or Immediate Past President. Additionally, appointed Chairs of the five Standing Committees (Sections 2.3 and 3.0) are non-voting members of the Executive Commit-tee. The Executive Committee conducts monthly hour-long teleconferences and minutes of these meetings are also available on the password-protected section of the website.

Following Nomination and Election House Rules that were updated in 2013, and with input from Board members, an ad hoc Nominating Committee including one representative from each WHO region, identified candidates for two positions becoming available in spring 2014. These were the Vice-President and combination Secretary/Treasurer posts. Incumbents of these two positions are permitted to serve up to three consecutive terms, and both were will-ing. The election was conducted in December 2013. Appendix C displays photos and contact information for all current Executive Committee voting members.

2.3 Standing Committees

Five Standing Committees focus on areas of prime importance to the mission of the WBMT, as identified by the Executive Committee. Most of these committees were created in 2008, and co-Chairs were appointed at that time. The majority of WBMT project work is accomplished by these Standing Committees:

Donor Issues

Education and Dissemination of Information

Graft Processing

Transplant Center/Recipient Issues

Regulation/Accreditation [the international Alliance for Harmonization of Cellular Therapy Accreditation (AHCTA) serves in this capacity]

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Two or three co-Chairs lead each committee. These co-Chairs also participate in the ongoing work and decisions of the Executive Committee. Any interested individual belonging to any one (or more) of the Member Societies is eligible to join these committees; membership is solicited periodically.

In early 2013, the Board approved development of an additional Standing Committee, the Nu-clear Accident Committee. Implementation of such a committee within WBMT is ongoing; how-ever, in November 2013, individuals represented both WBMT and WHO interests (in Ho Chi Minh City, Vietnam) and agreed in principle with the APBMT group to cooperate in their re-gional efforts and to facilitate a similar approach with other existing groups with a nuclear acci-dent focus.

Because the committees are project driven, they meet with varying frequency, usually by tele-conference. They also take advantage of related international meetings attended by many of their members for in-person dialog.

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3.0 STANDING COMMITTEE ANNUAL REPORTS AND 2013 ACCOMPLISHMENTS

3.1 Donor Issues Committee

Committee Mission: The mission of the Donor Issues Committee is to recommend to the Executive Committee poli-cies, programs, and actions in the area of any/all issues pertaining to the identification of stem cell donors [bone marrow (BM), peripheral blood (PB) and cord blood (CB)], harvesting proce-dures, product transportation, donor safety practices, and outcomes/long term follow-up with-in a member collection center; this includes the conduct of individuals and processes related to these procedures and practices.

Leadership: The co-Chairs of this Standing Committee are:

Jorge Halter (Member Society, EBMT)

Vanderson Rocha (Member Society, WMDA)

Meetings/Teleconferences: This Standing Committee met in person on April 9, 2013, in London, UK. There were no sched-uled teleconferences.

Completed Projects: During 2013, this Standing Committee completed the following projects:

Participation in the Essential Elements project under project leadership of Alliance for the Harmonization of Cellular Therapy Accreditation (AHCTA; K. Loper, Chair);

Completion of the 3rd Donor Outcome Workshop, held in September 2013 in Vienna;

Speaker, Chair, and planning contribution to the 2013 Workshop in Brazil.

Ongoing Projects: This Standing Committee continues to work on the following projects:

Development of donor eligibility criteria for pediatric or elderly donors and donors with comorbidities. The project aims to provide recommendations on donor eligibility criteria for donors who would not qualify as healthy volunteer unrelated donors. Leadership: WBMT Standing Committee on Donor Issues. [Note: this initiative was on the program of the September 2013 Donor Outcome Workshop in Vienna noted above (local organizers: Medical University Vienna, Austrian Registry for unrelated hematopoietic stem cell donors).] Three papers with the results of this initiative are currently in preparation; the targeted date of completion is 2014.

Completion of Program Planning for the 2014 Workshop in South Africa.

Global survey on the use of cord blood grafts. The project aims to understand the use of cord blood grafts and exchange of cord blood grafts among different countries, cord blood banks and donor registries. This project involves many participants of WBMT, such as Eurocord, EBMT, WMDA, NMDP, CIBMTR, etc.; the targeted date of completion is 2014/2015.

Future Plans: This Standing Committee has identified the following projects for initiation during 2014:

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Preparing for a 4th Donor Outcome Workshop in 2015;

Authoring recommendations for cord blood graft selection.

Publication:

Halter JP, van Walraven SM, Worel N, Bengtsson M, Hägglund H, Nicoloso de Faveri G, Shaw BE, Schmidt AH, Fechter M, Madrigal A, Szer J, Aljurf MD, Weisdorf D, Horowitz MM, Greinix H, Niederwieser D, Gratwohl A, Kodera Y, Confer D. 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 Transplant. 2013 Feb;48(2):220-5. Epub 2012 Jul 9. PubMed PMID: 22773129.

3.2 Education and Dissemination Committee

Committee Mission: The mission of the Education and Dissemination Committee is to recommend to the Executive Committee policies, programs, and actions in the area of any/all issues pertaining to data col-lection/sharing as well as the storage, publication, authorship, and acquisition of collected data by any Society Member; this includes the conduct of Society individuals and security matters and processes related to these procedures and practices. This committee collaborates with all partners within the WBMT and assists in “single voice” preparation of opinion or advisory mate-rials for the WHO.

Leadership: The co-Chairs of this Standing Committee are:

Eliane Gluckman (European School of Hematology, ESH and Eurocord)

Didi Jasmin (ESH)

Meetings/Teleconferences: This Standing Committee met in person on April 9, 2013, in London, UK.

Completed Projects: During 2013, this Standing Committee completed the following projects:

Publication of the 6th Edition of the ESH-EBMT handbook on hematopoietic stem cell transplantation;

Translation of the ESH-EBMT Handbook into Turkish with the collaboration of the Turkish Society of Hematology;

ESH-EBMT training course in Syracuse, Italy, May 2013;

Organisation of the World Cord Blood Congress and Innovative Therapies of Sickle Cell Disease in Monaco, October 2013;

Speaker, Chair, and planning contribution to the 2013 Workshop in Brazil.

Ongoing Projects: This Standing Committee continues to work on the following projects:

Translation of the ESH-EBMT Handbook into Portuguese with the help of the Brazilian Society of Hematology;

Organization of an ESH-EBMT training course Vienna, Austria, May 2014;

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Organization of an HSCT training course in Brazil in 2014;

Completion of Program Planning for the 2014 Workshop in South Africa.

Future Plans: This Standing Committee has identified the following projects for initiation during 2014:

Developing new educational tools (e.g., e-learning program, webinar conferences);

Developing online training programs;

Participating in the creation of an International Continuing Medical Education (CME) ac-creditation plan.

Publications: There were none in 2013; however, the following publication was the result of the efforts of this Standing Committee in past years and, in addition to wide distribution to other groups throughout 2013, is now available online:

Haematopoietic stem cell transplantation 2012 6th version. Editors J. Apperley, E. Carreras, E. Gluckman, T. Masszi and distributed by Chugai through the ESH website: http://www.esh.org/publications/.

3.3 Graft Processing Committee

Committee Mission: The mission of the Graft Processing Committee is to recommend to the Executive Committee policies, programs, and actions in the area of any/all issues pertaining to the handling of a har-vested product: storage, preparation and manipulation equipment, product transportation practices, and documentation within a member cell processing center; this includes the conduct of individuals and processes related to these procedures and practices.

Leadership: The co-Chairs of this Standing Committee are:

Mickey Koh (Member Society, International Sociey of Blood Transfusion, ISBT)

Carolyn Taylor [Member Society, Foundation for the Accreditation of Cellular Therapy, (FACT)]

Meetings/Teleconferences: This Standing Committee met on April 9, 2013, in London, UK and on April 22, 2013, in Aukland, New Zealand. There were no scheduled teleconferences.

Completed Projects: During 2013, this Standing Committee completed the following projects:

Manuscript submission to Bone Marrow Transplantation: “Minimal Requirements and Essential Features for Setting up a Stem Cell Processing Laboratory” from members of the graft processing subcommittee;

Development of a comprehensive list of “Frequently asked Questions” (FAQs) for public access on WBMT website;

Speaker, Chair, and planning contribution to the 2013 Workshop in Brazil;

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Member (Tom Leemhuis) participation in the AABB (formerly known as American Asso-ciation of Blood Banks) Webinar in November 2013; lectured on “Setting up a Stem Cell Processing Laboratory“. Committe Chair (Mickey Koh) chaired the Webinar session.

Ongoing Projects: This Standing Committee continues to work on the following projects:

Continuing updates to FAQs document: Project Leader, Carolyn Taylor;

Collaborating with ISCT on the issue of Cell Therapy Medical Tourism in hopes of pre-senting this important topic to the WHO General Assembly;

Completing Program Planning for the 2014 Workshop in South Africa.

Future Plans: This Standing Committee has identified the following projects to initiate during 2014:

Creating a map of Cell Processing laboratory capabilities worldwide;

Collaborating with ISCT on the issue of Cell Therapy Medical Tourism in hopes of pre-senting this important topic to the WHO General Assembly;

Planning the 2014 Workshop in South Africa.

Publication: The following manuscript was the result of the efforts of this Standing Committee:

Minimal Requirements and Essential Features for Setting up a Stem Cell Processing La-boratory: Leemhuis T, Padley D, Keever-Taylor C, Teshima T, Lanza F, Chabannon C, Sza-bolic P, Bazarbachi A, Koh M; on behalf of the Graft Processing Subcommittee of the Worldwide Network for Blood and Bone Marrow Transplantation (WBMT). Submitted to BMT in July 2013 and responded to reviewer queries in December.

3.4 Transplant Center/Recipient Committee

Committee Mission: The mission of the Transplant Center/Recipient Committee is to recommend to the Executive Committee policies, programs, or actions in the area of any/all recipient issues pertaining to the performance of hematologic transplantation and other cellular therapies/procedures within a member transplant center; this includes recording recipient outcomes, maintenance of records and the conduct of individuals and processes carrying out these procedures and practices.

Leadership: The co-Chairs of this Standing Committee are:

J. Douglas Rizzo (Member Society, CIBMTR)

Jane Apperley (Member Society, EBMT)

Marcelo Pasquini (Member Society, CIBMTR)

Meetings/Teleconferences: This Standing Committee met in person on April 7, 2013, in London, UK. There were no sched-uled teleconferences.

Completed Projects: During 2013, this Standing Committee completed the following projects:

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Transplant center chapter and summary contribution for insertion into oncoming manu-script describing outcome of Hanoi Workshop in November 2011;

Speaker, Chair, and planning contribution to 2013 Workshop in Brazil.

Ongoing Projects: This Standing Committee continues to work on the following projects:

Recommending “Minimal requirements” for reporting data to a registry; implemented by APBMT participating centers in 2012;

Reconciling and mapping transplant center identities between the three largest out-comes registries (e.g., APBMT, CIBMTR, EBMT); awaiting final EBMT approval;

Presenting web-based (Google-map) application for transplant center world map of lo-cations and center characteristics (requires funding);

Providing leadership for the Research Data Activities Task Force;

Assisting in the development of the original Global Transplant Center Number (GTCN) concept and also suggesting an alternative approach permitting centers a web-based tool to describe themselves using a unique code and to provide activity data to the WBMT (requires funding);

Completing program planning for the 2014 Workshop in South Africa.

Future Plans: This Standing Committee has identified the following projects to initiate during the 2014:

Completing the “Minimal Requirements” document; submit for publication.

Publication: The following manuscript was the result of the efforts of this committee:

Challenges and Opportunities for HSCT Outcome Registries; Perspective from Interna-tional HSCT Registries Experts: Aljurf M, Rizzo J D, Mohty M, Hussain F, Madrigal A, Pas-quini MC, Passweg J, Chaudhri N, Ghavamzadeh A, El Solh H, Atsuta Y, Szer J, Kodera Y, Niederweiser D, Gratwohl A, Horowitz MM. Submitted to BMT in late 2013 and re-sponded to reviewer queries in March 2014.

3.5 Regulation and Accreditation Committee

*(managed by the Association for the Harmonization of Cellular Therapy Accreditation; AHCTA)

Committee Mission: The mission of the Regulation and Accreditation Committee is to recommend to the Executive Committee policies, programs, and actions in the area of any/all issues pertaining to regulatory matters, practices and codes with both inter- and intra-national implications. This involves pro-cedures related to all activities of the remaining four Standing Committees. In its vigilance to avoid duplication of efforts, WBMT members agreed early (2009) that AHCTA shall fulfill the role of its Accreditation Committee.

Leadership: The Chair of this Standing Committee is:

Kathy Loper (Member Society, AABB)

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Meetings/Teleconferences: The committee generally meets by teleconference once per month (the first Monday of the month) and in person once per year, as international conference attendance permits. During 2013, this Standing Committee met twice in person and held nine committee calls as well as several project team calls.

Completed Projects: During 2013, this Standing Committee completed the following projects:

Submission of paper describing outcomes and results of AHCTA survey on training practices for professionals collecting hematopoietic progenitor cells (HPC), apheresis and HPC, cord blood;

Completion of draft paper describing recommendations and considerations for practice when training collection staff for HPC, apheresis and HPC, cord blood;

Launch of survey of training practices for HPC and bone marrow collection;

Resource update on website, www.ahcta.org;

Authorship of a letter to WBMT/WHO supporting ISBT128 standard labeling for cellular therapy products;

Speaker, Chair, and planning contribution to the 2013 Workshop in Brazil.

Ongoing Projects: This Standing Committee continues to work on the following projects:

Completing the training practices survey for laboratory staff. Once completed, the recommendations will be submitted for publication. Project Leads: C Keever-Taylor; I Cortenbach-Slaper.

Completing program planning for the 2014 Workshop in South Africa.

Future Plans: This Standing Committee hopes to identify during 2014 new projects that would serve the HSCT community and align with the mission of AHCTA and WBMT.

Publication: The following manuscript was the result of the efforts of this Standing Committee:

Training Practices of HPC(A) and HPC(CB) Collection Staff: Analysis of a Survey by the Al-liance for Harmonisation of Cellular Therapy Accreditation; Celluzzi CM, Keever-Taylor C, Alurf M, Koh K, Rabe F, Rebulla P, Sacchi N, Sanders J, McGrath E, Loper, K on behalf of The Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA). Submitted to Transfusion in December 2013.

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4.0 WBMT ACTIVITIES AND 2013 ACCOMPLISHMENTS

The WBMT engages in a variety of activities including:

Generating an annual global survey of HSCT activity;

Conducting scientific and educational conferences;

Developing consensus guidelines for optimum delivery of HSCT services and accreditation of HSCT facilities;

Collaborating and consulting with the WHO to promote excellence in HSCT, stem cell donation and cellular therapy.

4.1 Annual Global Survey

WBMT leaders agreed in early formative years that a first initiative should be to conduct annual global surveys of activity performed by transplant centers (Appendix D1 and D2); a minimal yet essential level of activity information is requested of participating centers. The annual survey displays volume of, and main indications for, allogeneic and autologous HSCT activity. These data were previously unknown, and centers were not represented on a map. WBMT needed this baseline information to support future projects and assist countries in increasing their ac-tivity levels and/or in the development of new transplant programs.

The WBMT survey reporting sheet is available on the website (http://www.wbmt.org/en/ wbmt-survey), along with disease indications for HSCT and accompanying main- and sub-class codes for use in completing the survey. WBMT continues to promote the annual survey by pub-lishing findings biannually (Section 6.0) and presenting results periodically at international meetings (Appendix E); data are presented internationally at least once annually. WBMT also encourages other, newer groups forming their own registries to participate in the survey [e.g., Latin American Blood and Marrow Transplant Society (LABMT)]. These data are also provided to the Global Observatory for Donation and Transplantation (Section 4.1.1).

In late 2012, a new tool (Transplant Activity Survey; TAS) was designed for the EBMT Activity Survey that allows the reporting of transplant activity via the web using a simple, user-friendly input form that is similar to the reports (easy, single page record) already being provided to WBMT via a regional transplant society, national Registry or at the team/center level – and mathematical calculations are performed automatically avoiding human error. Activity data can still be entered at either the country or center level.

These data do not represent an outcome registry, but the TAS is a mechanism by which each country’s annual data can be registered to the WBMT (in the format of the survey sheet that WBMT has used historically) and put to further use within the reporting organization.

These data are used in the following ways.

4.1.1 Team access

These activity data can be used at the team level for those countries/societies (e.g. LABMT) that do not have an existing data collection system.

If an outcome registry were to be developed, it could potentially use the TAS to identify the activity in those countries that are outside other data collection systems (e.g., CIBMTR, EBMT,

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etc.), providing a mechanism for follow-up. During the Salvador Workshop, an idea was pre-sented suggesting that outcome data reported to the CIBMTR could be provided back to new reporting teams in the future via its “Data Back to Center” Program. This project remains a work in progress.

4.1.2 Organización Nacional de Transplantes, ONT

Data on international use of HSCT are gathered inconsistently across the globe but usually by registries and professional societies. The Department of Essential Health Technologies of the WHO and the Spanish National Transplant Organization (Organización Nacional de Transplant-es, ONT) established the Global Observatory on Donation and Transplantation beginning in 2007. These collaborative activities attempt to meet the requirements of the 57th World Health Assembly Resolution WHA57.18. This resolution suggests that the collection of global data on the practices, safety, quality, efficacy and epidemiology of transplantations, their global availa-bility for all those concerned, including professionals, patients, politicians and the general pub-lic, are all recognized as a prerequisite for global improvement of, and better access to, trans-plantations [(Organs, Tissues and Cells, (2), 91-94, 2007].

One goal of the Observatory is the development of a global database on donation and trans-plantation. WBMT Member Societies, particularly the WMDA and Bone Marrow Donors Worldwide (BMDW), contributed substantially by providing unrelated donor information from their own databases to this Observatory databank. WBMT provided its first activity contribution in 2012, the Global Survey data from 2006-2008, and now updates these data as they become available.

4.2 Scientific and Educational Conferences

4.2.1 Joint Scientific/International Symposia Conferences are an important activity of the WBMT for communicating with other clinicians and researchers. WBMT conducts an annual 90 minute Scientific Symposium first presented during the US-based CIBMTR BMT Tandem Meetings (co-sponsored with the American Society for Blood and Marrow Transplantation, ASBMT) each February, and then repeated during the annual EBMT meeting in spring. These meetings represent the premier gathering in the US and in Europe for clinicians and researchers interested in HSCT. The focus is similar for each of the two WBMT Symposia with the same topics, but often with different expert speakers due to lo-gistical considerations. See Appendix F for a list of annual Symposia programs since WBMT be-gan coordinating them in 2009.

In addition to celebrating a one millionth transplant occurring in late 2012, the global transplant community also sadly lost two respected leaders in close succession in December 2012 and January 2013: Drs. E. Donnell Thomas and Karl Blume. The WBMT focused its popular 2013 Symposia almost entirely on a tribute to E. Donnell Thomas in particular as the “father of hema-topoietic stem cell transplant” and the impact he had on the evolution of this field. All global regions were represented with reports on the growth and current status of transplantation in their areas. These proved perfect settings in which to capitalize on the importance of, and to encourage, reporting transplant outcomes to registries and to emphasize the value of those

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data on improving outcomes and on moving the field forward towards the next millionth trans-plantation milestone. Planning for the 2014 sessions (Appendix F) occurred during late 2013 but was complicated by the sad loss of yet another leader in the HSCT community, Professor John M. Goldman, in De-cember. He was scheduled to speak at both 2014 WBMT sessions.

4.2.2 WBMT Workshops The WBMT also sponsors Workshops in regions with constrained resources, a demonstrated need and interest, and clinicians who wish to expand existing transplant programs or to start a new program. These activities are aimed at regions where resources and unique factors present challenges to clinicians wanting to provide easier access to their peoples in need of this modali-ty. The WBMT leverages the skills and expertise of its Education and Dissemination Standing Committee and the European School of Haematology (ESH, a WBMT Member Society) along with all other Standing Committees in planning these programs.

A first two-day Workshop (and associated one-day Scientific Symposium) was conducted in Ha-noi, Vietnam, in late 2011, in cooperation with the WHO and in partnerships with the APBMT and a local Vietnamese Organizing Committee. A descriptive manuscript is near completion for submission to two peer-reviewed journals: Blood and Marrow Transplantation and Biology of Blood and Marrow Transplantation.

One important result of the Hanoi Workshop was the suggestion that WBMT conduct training programs for physicians who lead transplant programs abroad. Since then, several teaching fellowships materialized during 2013 including practitioners from Mongolia, Qatar, the Philip-pines and Cambodia cross-training in either Japan or Germany. Another positive outcome of this Workshop was the networking opportunity that resulted in Myanmar representatives es-tablishing an HSCT program under the guidance of WBMT members who participated in the 2011 Workshop.

4.2.2.1 2013 Brazilian Experience With these successes in mind, and a commitment by the WBMT Board to support the Latin American Blood and Marrow Transplantation Society (a new WBMT Member Society in 2013), a local organizing committee indicated strong interest in co-hosting a Workshop with a Program similar to that conducted in Hanoi. A Meeting Planning Group (Geneva-based MCI) was selected in December 2012 to support the logistics of this second Workshop/Scientific Symposium. After many months of planning during 2013, this Workshop was successfully conducted October 3-5, 2013, in Salvador-Bahia, Brazil, and was attended by representatives from 11 regional countries where each described HSCT activity in their respective country. As was true in 2011, a broad spectrum of expert planners and presenters were from Europe, the Far East, Mediterranean region, and the U.S., augmenting a cadre of regional speakers. Though too early for complete assessment, indications onsite and since are that participants thought this to be a successful and valuable collaborative venture.

Programs for both the Hanoi and the Salvador-Bahia Workshops are available at www.wbmt.org.

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Finally, the WBMT Board voted in December 2013 to proceed quickly in planning a similar Workshop in Africa during 2014, provided sufficient funds can be procured.

4.2.3 Donor Outcome Workshop 2013 The WBMT Donor Issues Standing Committee, having sponsored two successful Donor Out-come Workshops previously (one in 2009, the other in 2011), conducted a third in September 2013 in Vienna, Austria. Recommendations on suitability criteria for pediatric and elderly do-nors as well as donors with comorbidities were discussed during a two day meeting and are currently prepared for publication. The accomplishments of this committee, as a result of these Workshops, include generation of several publications describing recommendations for minimal datasets for collecting donor data and assessing donor outcomes (Section 3.1; Appendix G).

4.3 Collaboration with the WHO

As noted previously, a WHO representative has been involved with WBMT activities since the earliest concept development meetings. WBMT maintained a “working relationship” with the WHO for almost four years thereafter when, meeting important criteria, it was officially invited to apply for NGO status. NGO status provides WBMT with the opportunity to continue its work on a more formal basis in partnership with the WHO in promoting excellence in HSCT, stem cell donation, and cellular therapy. These efforts all came to fruition with the January 2013 NGO status approval which, as implied above, brings with it partnership demands and participation in other WHO initiatives in pursuit of mutual educational, scientific, and philanthropic missions.

An example of a WHO initiative in which WBMT representatives participate is the ongoing NO-TIFY Project having attended a first meeting in Bologna in 2011 and remaining involved includ-ing most recently during a December 2013 meeting in Brasilia, Brazil. One sub-project of the broader NOTIFY Project is referred to as BIG V&S (Bologna Initiative for Global Vigilance and Surveillance), coordinated by the WHO and the Italian National Transplant Centre (CNT) in fur-ther collaboration with the SOHO V&S (Vigilance and Surveillance of Substances of Human Origin) project.

An important accomplishment of this group of experts was the development of the NOTIFY Li-brary – a large database launched in December 2013 for access to global data revealing in-stances of adverse outcomes. WBMT was in a unique position to make important recommenda-tions to this group in Brasilia including suggestions regarding changes in cell type taxonomy data items and better use of keywords specifically related to cellular therapies contained with-in. WBMT representatives also recommended that an editorial board be formed including more specialists in hematopoietic progenitor cell therapies and to improve website navigation pro-cesses, etc.

The 2012 NGO application process included distinction of this and other WBMT ongoing pro-jects in collaboration with the WHO as well as those projected for the subsequent three-year period should WBMT be approved as an NGO partner. As excerpted from the application, Ap-pendix B details both those activities in progress and/or completed at the time (Subsection 8.1; “Activities carried out jointly with WHO during the preceding two-year period”) and those planned (Subsection 8.2, “Details of planned collaborative activities with WHO for the coming three-year period”).

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Those in progress or already completed then were:

Collect and share data (Section 4.1);

Conduct Workshops (Section 4.2.2, 4.2.3);

Provide technical and scientific support (Section 4.2.1, 4.2.2, 4.3 and 4.4);

Foster and shepherd development of regional HSCT societies (Section 4.5).

Those activities to which WBMT committed in its NGO application (and were subsequently ap-proved) are:

Work with the Global Observatory on Donation and Transplantation (Section 4.1);

Promotion of access to HSCT – stem cell donation (Section 4.2.2);

Develop a Donation Guidance Document (Section 4.2.3);

Promotion of access to HSCT – transplantation (Section 4.2.2 and 4.5);

Technical and Scientific Input on Safety and Quality of HSCT (Section 4.2.1, 4.2.2, 4.3 and 4.4);

Global Consultation on Ethics, Safety and Access to HSCT (Section 4.2.1 and 4.2.2);

Initiative for Global Vigilance and Surveillance of Adverse Reactions and Events (Section 4.3);

Consultation Services (Section 4.0; ad hoc).

These final eight activities form the foundation for the continued work of the WBMT.

4.4 Consensus and Guideline Initiatives

The primary purpose of the WBMT is to serve as a single voice – at a global level – for HSCT and related issues. With the support of its Board, WBMT publicizes its sentiments on controversial or critical matters on its website and/or collaborates with other likeminded groups in opinion solidarity. To date, this includes WBMT positions on support of standardized product labelling and rejection of financial reimbursement for donation of cellular products. WBMT continues to support these two efforts as described here:

Working through its Accreditation and Regulation Standing Committee (e.g., AHCTA), general support was announced in 2012 for global implementation of the International Society of Blood Transfusion ISBT 128 coding and labeling schema in order to improve global traceability and enhance patient safety in the utilization of blood products worldwide. WBMT contributed to the development of a common nomenclature for products in use in cellular therapy which is reflected in globally applied coding systems, in particular WBMT promoted the adoption by the global community of the coding sys-tem ISBT128. This statement can be found at: http://wbmt.org/.

During 2013, WBMT support for this initiative was strengthened further by approving the International Council for Commonality in Blood Banking Automation (ICCBBA) appli-cation for Member Society status. ICCBBA is responsible for managing the ISBT 128 cod-ing and labeling schema noted above.

Also in 2012, the WBMT publicly opposed compensation of marrow donors by joining a consortium of leading global cell therapy organizations to challenge this concept. A link

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for more information about this initiative can be found at: http://wbmt.org/ and also at: http://marrow.org/News/News_Releases/2012/Coalition_says_PBSC_donor compensation_poses_health_risks_to_patients_and_donors.aspx.

In addition, some Standing Committees have authored substantial works, either independently or collaboratively, on standardization of practice topics associated with their committee man-dates (Section 3.0 and Appendix G).

In 2013, WBMT began another initiative having to do with cellular tourism, most importantly, the risks involved. The International Society of Cellular Therapy (ISCT), another WBMT Member Society, first took the lead in collaborating with others to author a statement warning the pub-lic of considerations when going abroad seeking cellular therapy of one kind or another for a medical problem. WBMT was invited to participate in this work and, with its worldwide reach, is now highly focused on preparing a statement about this issue during 2014.

Lastly, in late 2013, WBMT was invited by the European Directorate for the Quality of Medi-cines & HealthCare (EDQM) Council of Europe to comment on revisions of their Microbiological Control of Cell-Based Preparations chapter.

4.5 Supporting Other HSCT Global Activities

WBMT has been instrumental in supporting the successful development of the new LABMT. The LABMT first met in 2010 and there approved an interim Board, then passed bylaws in December 2012. The full group met during the 2013 BMT Tandem Meetings in Salt Lake City; its applica-tion for formal WBMT Member Society status was approved by the WBMT Board in February 2013. During the October 2013 Workshop in Salvador-Bahia, Brazil (see 4.2.2.1), the group con-ducted a business meeting during which an Executive Committee was elected; the committee has been meeting regularly since.

Similarly, in November 2011, the WBMT became involved in supporting establishment of an African Blood and Marrow Transplant Group (AFBMT) when invited to attend a meeting in Ni-geria which included South African representatives as well. They are of similar mind to form a broader African group of HSCT clinicians. A small, interim Executive Committee now exists to begin the building process; a leader is in place. The WBMT places high focus on the AFBMT as it represents the single remaining continent that has not uniformly reported transplant activity or outcome data.

Both groups have been encouraged to commit to participate in the annual WBMT global activity survey noted above (section 4.1). A positive outcome of the Workshop in Latin America is the numerous new transplant centers providing activity data to this survey. The same consequence is anticipated as a result of the planned 2014 Workshop in Africa. This is an important step for-ward in addressing the current gap in acquisition of data from these regions.

Lastly, WBMT has permitted use of its logo in order to assist in attracting attention to other group meetings such as a recent Sickle Cell Disease conference held in Regensburg, Germany.

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4.6 Website Development

The WBMT website, launched in 2010, is hosted and serviced in Bern, Switzerland, by the Swiss Blood Stem Cells group. Identifying itself via the internet was an important first step in the evo-lution of the WBMT. Substantial effort is placed continually into posting current documents such as meeting minutes and Workshop/Symposium Programs as well as important newswor-thy items (e.g., approved NGO status with the WHO, one millionth transplant announcement, consensus statements, etc.).

During 2013, the website was particularly effective in dissemination of the above mentioned one millionth transplant announcement. In collaboration with the NMDP, a press release was prepared in nine languages (http://www.wbmt.org/en/general-information-bylaws-presentations/one-million-transplants/) and posted on the site making it widely available. Addi-tionally, the notice was published in various newspapers globally and information of the activity presented in local press conferences.

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5.0 FUTURE AIMS

WBMT continues to evolve, and though it has identified many activities with which it wants or needs to be involved, limited resources and availability of this volunteer group of leaders and committee members affect the selection of projects for its portfolio. In addition to the plans identified in Section 3.0 by each of the Standing Committees, priority activities the Executive Committee is assessing for the near future are:

Continue close collaboration with the WHO on global projects relevant to HSCT and fulfilling WBMT responsibilities as an NGO.

Complete the Honoi Workshop manuscript. o Publish an algorithm for establishing a new HSCT program as identified during

the Hanoi Workshop.

Complete the “one millionth transplant” manuscript including the 2008-2010 global survey results using Member Society data contributions.

Complete the Salvador Workshop report, and begin drafting its manuscript.

Conduct a Workshop in Africa (Capetown) during 2014. o Continue efforts in support of an AFBMT.

Pursue the initiative on cellular tourism in collaboration with WBMT Member Societies. o Report this work to the WHO General Assembly in May 2014.

Proceed with the mission of the Reserach Data Task Force for identification of proper procedures for research coordinated by the WBMT.

Since concept approval in February 2013, establish a Nuclear Accident Standing Committee to work in collaboration with existing committees to extend the concept of “speaking with one voice”.

Continue developing a related donor registry in association with the Donor Issues Committee’s long term agenda.

Continue support of transplant center twinnings and/or cross-training activities.

Continue efforts towards establishing a unique Global Transplant Center Number (GTCN) to improve data sharing capabilities at a global level.

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6.0 PUBLICATIONS AND ABSTRACTS HISTORY

Some works are published on behalf of WBMT whereas others are credited to a WBMT Stand-ing Committee. Appendix G displays the complete WBMT publication portfolio while identifying which entity is credited; it includes those submitted during 2013 but are still under review.

The manuscript describing the 2011 Hanoi Workshop is near completion for journal submission and will be credited to the entire Network.

A WBMT abstract history since inception is as follows:

The following abstract was submitted on behalf of the WBMT and accepted for poster presentation at the American Society of Hematology (ASH) meetings in December 2013:

Global Hematopoietic Stem Cell Transplantation (HSCT) At One Million: An Achievement Of Pioneers and Foreseeable Challenges For The Next Decade. A Report From The Worldwide Network For Blood and Marrow Transplantation (WBMT). Dietger Nieder-wieser, MD, Marcelo C Pasquini, MD, MS, Mahmoud D. Aljurf, MD, Dennis L. Confer, MD, Helen Baldomero, Luis Fernando Bouzas Sr., MD, MSC, PhD, Mary M. Horowitz, MD, MS, Minako Iida, MD, Yoshihisa Kodera MD, PhD, Jeffrey H. Lipton, MD, PhD, Machteld Oudshoorn, Eliane Gluckman, MD, Jakob R. Passweg, MD, Jeffrey Szer, MD, Nicolas Novitzky, MD, PhD, Jon J. van Rood, MD, Luc Noel, MD, J. Alejandro Madrigal, MD, PhD, Karl Frauendorfer, Alois Gratwohl, MD and Frederick R. Appelbaum, MD

The following abstract was presented as a poster on behalf of the WBMT at the ASH meetings in December 2012:

Clinical Allogeneic and Autologous Transplantation - Results: Poster II Global Trends in Hematopoietic Cell Transplantation. Helen Baldomero, Mahmoud Aljurf, MD, Luis Fernando Bouzas, MD, MSC, Alois Gratwohl, MD, Yoshihisa Kodera, MD, PhD, Jeff H Lipton, MD, J. Alejandro Madrigal, MD, PhD, Iida Minako, MD, Nicolas Novitzky, MD, PhD, Marcelo C Pasquini, MD, MS, Jakob R. Passweg, MD, Adriana Seber, MD, Jeffrey Szer, MBBS and Dietger Niederwieser, MD

The following abstract was presented orally on behalf of the WBMT at the ASH meetings in De-cember 2011:

Global use and trends in hematopoietic stem cell transplantation: A targeted approach for a widening gap. Dietger Niederwieser, MD, Helen Baldomero, Michael Gratwohl, Mahmoud Aljurf, MD, Luis Fernando Bouzas, MD, MSC, Mary Horowitz, MD, MS, Yoshihisa Kodera, MD, PhD, Jeff Lipton, MD, PhD, Iida Minako, MD, Marcelo C. Pasquini, MD, MS, Jakob Passweg, MD, Jeff Szer, MD, Alois Gratwohl, MD, Karl Frauendorfer for the Worldwide Network of Blood and Marrow Transplantation.For more information about items included in this report, please con-tact any WBMT Officer (Appendix C).

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APPENDIX A: MEMBER SOCIETIES

Organization Description

AABB www.aabb.org

AABB, formerly known as the American Association of Blood Banks, is an international non-profit association committed to advancing the practice and standards of transfusion medicine and cellular therapies to optimize patient and donor care and safety.

American Society for Histocompat-ibility and Immunogenetics (ASHI) www.ashi-hla.org

ASHI is a non-profit association of clinical and research professionals that is dedicated to advancing the science and application of histocompatibility and immunogenet-ics as well as advocating the highest standards of labora-tory testing in the interest of optimal patient care.

American Society of Blood and Marrow Transplantation (ASBMT) www.asbmt.org

ASBMT is an international association that promotes the advancement of the HSCT field by representing the in-terests of transplant clinicians and investigators as well as the patients they serve.

Asia Pacific Blood and Marrow Transplantation (APBMT) www.apbmt.org

A Founding Member: APBMT is an international organi-zation of HSCT researchers that allows physicians in Asian countries involved in HSCT to share their experi-ence and develop cooperative studies.

Australasian Bone Marrow Trans-plant Recipient Registry (ABMTRR) www.abmtrr.org

ABMTRR promotes HSCT research and helps provide access to and information about HSCT to people in Aus-tralia and New Zealand.

Bone Marrow Donors Worldwide (BMDW) www.bmdw.org

BMDW is a voluntary collaborative effort of stem cell donor registries and cord blood banks whose goal is to provide centralized information on the HLA phenotypes and other relevant data of unrelated stem cell donors and cord blood units and to make this information easily accessible.

Center for International Blood and Marrow Transplant Research (CIBMTR) www.cibmtr.org

A Founding Member: CIBMTR collaborates with the global scientific community to advance hematopoietic cell transplantation and cellular therapy research worldwide. A combined research program of the Na-tional Marrow Donor Program® and the Medical College of Wisconsin, CIBMTR facilitates transplant outcome research that has led to more than 800 peer-reviewed publications. These publications have contributed to increased survival and an enriched quality of life for many transplant patients.

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Organization Description

Eastern Mediterranean Blood and Marrow Transplantation (EMBMT) www.embmt.org

EMBMT promotes all aspects of patient care, academic, and research activities associated with HSCT in eastern Mediterranean countries with the goal of sharing expe-rience, initiating cooperative trials, and establishing common strategies to advance the field of HSCT.

Eurocord www.eurocord-ed.org

Eurocord promotes national and international collabora-tions and disseminates HSCT knowledge. The Eurocord registry operates on behalf of the EBMT, and Eurocord works in close collaboration with Netcord cord blood banks and EBMT centers and database.

European Federation for Immuno-genetics (EFI) www.efiweb.eu

EFI aims to promote research in immunogenetics, histo-compatibility testing, and HSCT. It promotes the ad-vancement of immunogenetics in Europe and supports research and training in the field.

European Group for Blood and Marrow Transplantation (EBMT) www.ebmt.org

A Founding Member: EBMT aims to improve outcomes of HSCT and provide information to the public about developments in the field by sharing the experience of European centers and encouraging cooperative research among scientists and physicians in the HSCT field.

European Marrow Donor Infor-mation System (EMDIS) www.emdis.net

The EMDIS system integrates the databases of European blood and marrow donor registries allowing data ex-change from and to heterogeneous systems and nation-wide area networks.

European School of Haematology (ESH) www.esh.org

ESH is a non-profit institution for continuing education that promotes and facilitates access to research in he-matology and related disciplines in Europe, North Amer-ica, North Africa, and the Middle East. ESH also develops tools for continuing education produced in collaboration with international experts in the field.

Foundation for the Accreditation of Cellular Therapy (FACT) www.factwebsite.org

FACT is a non-profit organization that establishes stand-ards for high-quality medical and laboratory practices in cellular therapies for the purposes of voluntary inspec-tion.

International Council for Common-ality in Blood Banking Automation (ICCBBA) http://iccbba.org/

ICCBBA is a not-for-profit, tax exempt, non-government organization responsible for management of the ISBT 128 Information Standard for Blood and Transplanta-tion, a global standard for the terminology, identifica-tion, labeling, and information transfer of human blood, cell, tissue, and organ products across international bor-ders and disparate health care systems. It ensures the highest levels of accuracy, safety, and efficiency for the benefit of donors, patients, and ISBT 128 licensed facili-

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Organization Description

ties worldwide. The system features a unique, highly flexible, and comprehensive coding method for every collected product and provides international consistency to support the transfer, transfusion, or transplantation of blood, cells, tissues and organs.

International Society of Blood Transfusion (ISBT) www.isbtweb.org

ISBT is an international professional society that facili-tates knowledge about transfusion and transplantation science and medicine.

International Society of Cellular Therapy (ISCT) www.celltherapysociety.org

ISCT is a global association that promotes cellular thera-pies research by fostering international translational research, driving commercialization strategies, and providing education.

Joint Accreditation Committee-ISCT (Europe) & EBMT (JACIE) www.jacie.org

JACIE is a non-profit organization that assesses and pro-vides accreditation in the field of HSCT. Its primary aim is to promote high-quality patient care and laboratory per-formance in hematopoietic stem cell collection, pro-cessing and transplantation through an internationally recognized system of accreditation. It partners with EBMT, ISCT, and FACT.

Latin American Bone Marrow Transplantation group (LABMT)

The purpose of this group is to provide a mechanism through which Latin American Blood and Marrow Trans-plant and Hematology groups can collaborate and en-gage in scientific and educational activities and endeav-ours to promote excellence in stem cell transplantation, stem cell donation, cellular therapy and hematologic practices. Activities include data collection and sharing outcome information.

Netcord www.netcord.org

The International NetCord Foundation is a non-profit association of umbilical cord blood banks whose mem-bers comprise the largest source of high-quality cord blood grafts for patients in need of HSCT.

World Marrow Donor Association (WMDA) www.worldmarrow.org

A Founding Member: WMDA is a global association whose mission is to assure that high-quality stem cell products are available for all patients in need, while maintaining the health and safety of the volunteer do-nors.

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APPENDIX B: COLLABORATIVE ACTIVITIES WITH THE WHO

This section is excerpted from the 2012 WBMT application for non-governmental organization (NGO) status; it includes those activities to which WBMT remains committed for the next two years.

Activities Carried Out Jointly with WHO during the Preceding Two-Year Period

Global Database on Donation and Transplantation Data on international use of haematopoietic stem cell transplantation (HSCT) are gathered in-consistently across the globe, usually by registries and professional societies. WHO and the Spanish National Transplant Organization (Organización Nacional de Trasplantes (ONT)) estab-lished the Global Observatory on Donation and Transplantation. Among the goals of the Obser-vatory is the development of a global database on donation and transplantation. WBMT facili-tated access to its data for input into the Observatory database. With the help of WBMT, WHO webpages dedicated to HSCT were developed published and updated (http://www.who.int/transplantation/hsctx/en/index.html). WBMT data on the num-ber of HSCT transplantations per million population per country features were placed on the WHO website (http://www.who.int/transplantation/allogenic/en/index.html). International Workshop on HSCT in Emerging Countries With the cooperation of the Ministry of Health in Vietnam and WHO, WBMT organized the first international workshop on HSCT in emerging countries, Hanoi, Vietnam, November 2011. It is the beginning of an ongoing process to support the development of HSCT in low and middle income countries. Among the outcomes of the meeting was the initiation of long term collabo-ration plans between advanced and beginner centres in Mongolia, in the Philippines and other countries. A guidance document on the requirements for the development of HSCT will be de-veloped on the basis of the outcomes of the meeting. Technical/Scientific Support and Data WBMT extended technical and scientific support and or contributed data to the following initia-tives:

The “NOTIFY Project”, a joint venture by WHO and the Italian National Trans-plant Centre WHO, the Italian National Transplant Centre (CNT) and the EU-funded Project ‘Vigilance and Surveillance of Substances of Human Origin’ (SOHO V&S) joined forces to organize a global initiative aimed at raising the profile of vigilance and surveillance (V&S) of substances of human origin.

Among the aims of NOTIFY is a publicly accessible online global library of didactic cases of adverse reactions and events. Case histories from the registries of WBMT were contributed to NOTIFY.

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The NOTIFY project was launched after 6 months of preparatory work in a meet-ing of 113 invited experts from 36 countries that took place in Bologna, Italy from 7-9 February 2011. The resulting report and didactic papers together are in-tended to provide policy makers, as well as health care providers, with infor-mation about what work has already been done with respect to vigilance and surveillance and what further work in the view of the participants is needed. The contribution of WBMT is essential to assess cases of adverse events and reac-tions in cellular therapies as demonstrated during the further NOTIFY consulta-tion in Geneva on 5-6 July 2011.

WBMT contributed to the development of a common nomenclature for products in use in cellular therapy which is reflected in globally applied coding systems, in particular WBMT promoted the adoption by the global community of coding sys-tem ISBT128. Beyond hematopoietic stem cells, the WBMT has also contributed to initiate the work on a systematic nomenclature of adult, embryonic, and non-hematopoietic stem cells.

WBMT supported WHO in upholding the WHO Guiding Principles on Cell Tissue and Organ Transplantation, for instance by clarifying the lack of evidence to justi-fy autologous cord blood banks, or opposing the proposal of financial incentives for the donation of hematopoietic stem cells.

Latin American Network of Blood and Marrow Transplantation WBMT and WHO fostered the development of a Latin American Network of Blood and Marrow Transplantation.

Details of Planned Collaborative Activities with WHO for the Coming Three-Year Peri-od (Note: timeline began in January 2013 with two years remaining)

Work with the Global Observatory on Donation and Transplantation WBMT, in collaboration with the ABMTRR (Australasian group), APBMT, CIBMTR, EBMT, EMBMTR, Eurocord, WMDA and other Board Society Members, will support the updating of hematopoietic stem cell donation and transplantation (HSCT) data in, and published on, the website of the Global Observatory on Donation and Transplantation (GODT). The Global Data-base on Donation and Transplantation is one of the main areas of the GODT and works in col-laboration with the WHO providing data on solid organ donation and transplantation. It is the information platform designed to implement some of the requirements of the World Health Assembly Resolution WHA57.18. WBMT will contribute related and unrelated hematopoietic stem cell donation, including cord blood grafts, and transplantation data and analysis of region-al variations in indications, practices and outcome of HSCT by continuing its annual Activity Sur-veys. Results will be submitted for publication.

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Promotion of Access to HSCT – Stem Cell Donation WBMT, in collaboration with the WMDA and other organizations, will continue advocating for the promotion of voluntary hematopoietic stem cell donation of any origin, including support to the WHO in updating the relevant WHO web-pages mentioned above. A specific page will be developed to further spread information on volunteer stem cell donor activities including medi-cal requirements for donation, and access to volunteer donors and cord blood units in world-wide registries; it will highlight the remaining gaps taking into consideration the various forms of HSCTs. WBMT will also prepare a tentative algorithm to choose the most appropriate donor (including one haplotype mismatched family members) to perform HSCT at the best timing for the recipi-ent. Develop a Donation Guidance Document Development of the above mentioned guidance document (8.1, ii, Hanoi Workshop manuscript) is ongoing. WBMT, in collaboration with the WMDA and others, will develop a policy document in the form of an aide-mémoire following the consultations planned below to address ethics and essential medical and logistical pre-requisites for stem cell donation in low and middle in-come countries. Family donors will be included in this subject/activity requirement. Promotion of Access to HSC – Transplantation Following-up on the successful Hanoi Workshop on Allogeneic Blood and Marrow Transplanta-tion in Resource-constrained Environments, the WBMT, in collaboration with ESH and others, will coordinate a second meeting on HSCT in emerging countries, associating representatives of health authorities and professionals. This second workshop will be planned soon for late 2013 (or early 2014) following a “solicitation process plan” created by WBMT. The outcomes reference documents of the Hanoi workshop are in the process of being finalized and will be submitted for publication no later than fall 2012. They will need refinement and first experiences of implementation will have to be reviewed. Additionally thought must be given to the application of HSCT to congenital haemoglobin diseases prevalent in target countries. It is hoped that WHO will be able to be a co-sponsor of a next meeting, contributing to the partici-pation of low and middle income countries representatives. Technical and Scientific Input on Safety and Quality of HSCT It is expected that WHO will organize the fourth global consultation on regulatory requirements for human cells and tissue for transplantation in 2013 if funding allows. WBMT will provide es-sential technical and scientific input, in particular on mechanisms to implement global require-ments and professional standards for the safety and quality of HSCT. The WBMT global experi-ence will be used as a practical example for scientific and professional societies focused on oth-er tissue transplants such as the recently created Alliance of Eye Banking Societies.

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Global Consultation on Ethics, Safety and Access to HSCT WHO and the French Agence de la Biomédecine, are considering a global consultation on ethics, safety of and access to, HSCT as a preparatory step towards a global summit to be held in 2013 on therapeutic substances and products of human origin. WBMT, in collaboration with the WMDA and others, will collaborate on this initiative. This is tentatively to take place in June 2013. It will address inter–alia issues such as commercial donation of HSCT, trans-national do-nor registries or cord blood inventories evading domestic systems, and the economy of HSC procurement. Details are to be determined by WHO. Initiative for Global Vigilance and Surveillance of Adverse Reactions and Events WBMT already is, and will continue to be, a participant in the outcome to the above mentioned consultation, that is, the Bologna Initiative for Global Vigilance and Surveillance of Adverse Re-actions and Events (BIG V&S SARE). It will continue to play an essential role in its development by contributing its experts in the global annual consultation on V&S for substances of human origin and in the editorial workgroup in charge of events and reactions reported in HSCT for the NOTIFY library of didactic cases and by contributing to the notification of didactic cases through the registries of SARE held by WBMT members. A next meeting is tentatively scheduled for late 2012. Consultation Services WBMT will provide consultants following requests of Member States to WHO on advice for the development of national resources for HSCT services.

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APPENDIX C: EXECUTIVE COMMITTEE VOTING MEMBERS

President Dietger Niederwieser, MD Professor of Medicine, Dr. h. c. Division of Hematology and Medical Oncology Univ. of Leipzig, Johannisallee 32A 04103 Leipzig, Germany Tel: +49 341 97-13050 Fax: +49 341 97-13059 [email protected]

Vice-President Daniel Weisdorf, MD Professor of Medicine Director Adult Blood & Marrow Transplant Program University of Minnesota MMC 480, Minneapolis, MN 55455 USA Tel: +1 612 624 3101 Fax: +1 612 625 6919 [email protected]

President-Elect Yoshihisa Kodera, MD Department of Promotion for Blood and

Marrow Transplantation Aichi Medical University School of Medicine

21, Karimata Yazako, Nagakute-cho Aichi-gun Aichi 480-1195 Japan Tel: +81 561 62 3311 (Ext. 2375) Fax: +81 561 61 3180 [email protected]

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Treasurer/Secretariat Dennis Confer, MD Chief Medical Officer 3001 Broadway Street N. E. Suite 100 Minneapolis, MN 55413-1753 Tel: +1 612 362 3425 Fax: +1 612 845 0882 [email protected] www.marrow.org

Interim Executive Committee Member Hildegard Greinix, MD I. Med. Univ. Klinik, KMT Währinger Gürtel 18-20 A-1090 Wien Austria Tel: +43 1 40400 4402 Fax: +43 1 40400 5701 [email protected]

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APPENDIX D1: CENTER SITES THAT CONTRIBUTE DATA TO THE ACTIVITY SURVEY

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APPENDIX D2: COUNTRIES THAT HAVE CONTRIBUTED DATA

WHO Region

Country

*Maximum number of teams in any one survey year

2006-2010

Number of Teams

EMR/AFR Algeria 2

AMR/PAH Argentina 22

SEAR/WPR Australia 41

EUR Austria 13

EUR Belarus 2

EUR Belgium 20

EUR Bosnia and Herzegovina 2

AMR/PAH Brazil 35

EUR Bulgaria 2

AMR/PAH Canada 20

AMR/PAH Chile 1

SEAR/WPR China 48

AMR/PAH Columbia 4

AMR/PAH Costa Rica 3

EUR Croatia 3

EUR Cyprus 1

EUR Czech Republic 9

EUR Denmark 4

EMR/AFR Egypt 3

EUR Estonia 2

EUR Finland 7

EUR France 74

EUR Germany 108

EUR Greece 12

SEAR/WPR Hong Kong 3

EUR Hungary 6

EUR Iceland 1

SEAR/WPR India 24

EMR/AFR Iran 2

EUR Ireland 6

EUR Israel 8

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WHO Region

Country

*Maximum number of teams in any one survey year

2006-2010

Number of Teams

EUR Italy 98

SEAR/WPR Japan 381

EMR/AFR Jordan 1

EUR Kazakhstan 1

EUR Latvia 1

EMR/AFR Lebanon 2

EUR Lithuania 2

EUR Luxembourg 1

EUR Macedonia, FYR 1

SEAR/WPR Malaysia 10

AMR/PAH Mexico 5

EMR/AFR Morocco 1

EUR Netherlands 16

SEAR/WPR New Zealand 6

EMR/AFR Nigeria 1

EUR Norway 6

EMR/AFR Oman 1

EMR/AFR Pakistan 3

AMR/PAH Panama 2

AMR/PAH Paraguay 1

AMR/PAH Peru 1

SEAR/WPR Philippines 1

EUR Poland 18

EUR Portugal 6

EUR Romania 4

EUR Russian Federation 14

EMR/AFR Saudi Arabia 3

EUR Serbia 4

SEAR/WPR Singapore 5

EUR Slovak Republic 5

EUR Slovenia 1

EMR/AFR South Africa 7

SEAR/WPR South Korea 43

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WHO Region

Country

*Maximum number of teams in any one survey year

2006-2010

Number of Teams

EUR Spain 70

EUR Sweden 8

EUR Switzerland 9

SEAR/WPR Taiwan 17

SEAR/WPR Thailand 7

EMR/AFR Tunisia 1

EUR Turkey 30

EUR Ukraine 2

EUR United Kingdom 52

AMR/PAH United States of America 187

AMR/PAH Uruguay 5

AMR/PAH Venezuela 2

SEAR/WPR Vietnam 3

TOTAL 77 (74) 1533 (1516)

(……..) = previous year

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APPENDIX E: HISTORY OF BOARD MEETINGS

WBMT Board Business Meetings WBMT Participant Meetings 2014

Milan, Italy (March)

2013

Brasilia, Brazil (WBMT/NOFITY; December)

Teleconference (November)

Teleconference (July)

Geneva, Switzerland (WHO; May)

London, UK (Standing Committees; April)

Salt Lake City, UT, US (February)

2012

Atlanta, GA, USA (WBMT/LABMT; December)

Rome, Italy (WBMT/NOTIFY; November)

Teleconference (October) Hyderabad, India (APBMT; October)

St. Petersburg, Russia (WBMT/Russia; September)

Lagos, Nigeria (WBMT/AFBMT; September)

Manila, Philippines (WBMT/Philippine Society of Haematology; August)

Teleconference (June)

Geneva, Switzerland (April)

San Diego, CA, US (WBMT/LABMT; February)

2011

Teleconference (December)

Teleconference (September)

Rio de Janeiro, Brazil (SBTMO/LABMT; August)

Teleconference (June)

Teleconference (April)

Paris, France (Standing Committees; March)

Honolulu, HI, US* (February)

2010

Phuket, Thailand (APBMT; November)

Vienna, Austria (March)

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WBMT Board Business Meetings WBMT Participant Meetings Brussels, Belgium (WHO; February)

2009

Minneapolis, MN, US (November)

New York, NY, US (UN; October)

Nagoya, Japan (April)

Göteborg, Sweden (March)

2008

Minneapolis, MN, US (October) Geneva, Switzerland (WHO; October)

Firenze/Florence, Italy (March)

Tampa, FL (February)

2007

Minneapolis, MN, US (October)

Lyon, France (March)

*1st elected Board meeting

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APPENDIX F: INTERNATIONAL SCIENTIFIC SYMPOSIA HISTORY (2009-present)

2014

February, BMT Tandem Meetings (Dallas)

Hematopoietic Stem Cell Trasnplantation: Access and Affordability Co-Chairs: D. Niederwieser, MD; Y. Kodera, MD; D. Confer, MD; D. Wiesdorf, MD; H. Greinix, MD

Non-Government Organization (NGO): Status significance and opportunities of NGO (J. Nunez)

Cost of non-transplant therapy for hematologic malignancies (J. Apperley)

Alternative donor selection: o Haploidentical donor (X-J. Huang) o Cord blood stem cell transplantation (D. Wiesdorf)

April, EBMT Meetings (Milan)

Hematopoietic Stem Cell Trasnplantation: Access and Affordability Co-Chairs: D. Niederwieser, MD; Y. Kodera, MD; D. Confer, MD; D. Wiesdorf, MD; H. Greinix, MD

Non-Government Organization (NGO): Status significance and opportunities of NGO (J. Nunez)

Cost of non-transplant therapy for hematologic malignancies (J. Apperley)

Alternative donor selection: o Haploidentical donor (L. Luznik) o Cord blood stem cell transplantation (M. Eapen)

2013 February, BMT Tandem Meetings The Legacy of E. Donnall Thomas: 1 Million Hematopoietic Stem Cell Transplants Co-Chairs: D. Niederwieser, MD; Y. Kodera, MD; D. Confer, MD; H. Greinix, MD

E. Donnall Thomas: From Cooperstown to Global (F. Appelbaum)

Challenges to Future Growth: The Transplant Center Perspective o North America (R. Champlin) o Central/South America (C. Bonfim) o Asia-Pacific (A. Srivastava)

Challenges to Future Growth: The Donor Registry Perspective (D. Confer)

Challenges to Future Growth: The WHO Perspective (L. Noël)

Improving Research Collaborations to Move Forward (J. Apperley)

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April, EBMT Meetings The Legacy of E. Donnall Thomas: One Million Hematopoietic Stem Cell Transplants Co-Chairs: D. Niederwieser, MD; Y. Kodera, MD; D. Confer, MD; H. Greinix, M.D.

E. Donnall Thomas: From Cooperstown to Global (R. Storb)

Challenges to Future Growth: The Transplant Center Perspective o Europe (M. Mohty) o Eastern Mediterranean (M. Aljurf) o Africa (N. Novitzky)

Challenges to Future Growth: The Donor Registry Perspective (D. Confer)

Challenges to Future Growth: The WHO Perspective (L. Noël)

Improving Research Collaborations to Move Forward (M. Horowitz)

2012

WBMT Scientific Session Chair: D. Niederwieser, MD

WBMT Update (D. Niederwieser)

The Macroeconomics of Hematopoietic Stem Cell Transplantation (A. Gratwohl)

A Global View of Cord Blood Transplantation (V. Rocha)

The Fukushima Nuclear Accident – The Transplant Team Experience (S. Taniguchi)

2011

WHO and WBMT: A Model for Optimal Collaboration Between Scientists and Health Institutions Co-Chairs: D. Confer, MD; Y. Kodera, MD; and D. Niederwieser, MD

Update on WBMT Activity (D. Niederwieser)

Global HSCT Activity Survey 2007-2008 (H. Baldomero)

Report from the APBMT Congress: HSCT Activity and Plans for a Vietnam Meeting (Y. Kodera)

Harmonizing Standards in BMT – Improving Outcomes on a Global Scale (K. Loper)

WHO and WBMT a Model for Optimal Collaboration Between Scientists and Health Institutions (L. Noël)

2010

Worldwide Network for Blood and Marrow Transplantation (WBMT) Session Chairs: D. Niederwieser, MD and M. Horowitz, MD, MS

Update on Progress of WBMT (D. Niederwieser)

Challenges in Establishing HSCT Outcomes Registries in Developing Countries Asia-Pacific BMT Group (Y. Atsuta)

Eastern Mediterranean BMT Group (M. Aljurf)

Ethical Issues in Donation of Hematopoietic Stem Cells (A. Capron)

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2009

WBMT International Session (Supported by THERAKOS, Inc.) Co-Chairs: D. Niederwieser, MD; S. Davies, MD; Y. Kodera, MD; and M. Oudshoorn, PhD

Overview of Unrelated Adult and Cord Blood Donation: the WMDA Annual Survey (M. Oudshoorn)

Unrelated Donor Outcomes and Plans for Assessing Related Donor Outcomes: A Report from the NMDP/CIBMTR (D. Confer)

Related Donor Outcomes from the Japanese Registry: The Importance of Pre-registration (Y. Kodera)

Proposal for an EBMT Donor Outcome Registry (J. Halter)

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APPENDIX G: PUBLICATIONS LIST

Author(s) Title Citation Credited to:

Submitted in 2013 – remains under consideration

Celluzzi CM, Keever-Taylor C, Alurf M, Koh K, Rabe F, Rebulla P, Sacchi N, Sanders J, McGrath E, Loper, K on behalf of The Alli-ance for Harmonisation of Cellular Therapy Accreditation (AHCTA)

Training Practices of HPC(A) and HPC(CB) Collection Staff: Analysis of a Survey by the Alliance for Harmonisa-tion of Cellular Therapy Accreditation

WBMT Regulation and Accreditation Committee (AHCTA)

Aljurf M, Rizzo J D, Mohty M, Hussain F, Madrigal A, Pasquini MC, Passweg J, Chaudhri N, Ghavamzadeh A, El Solh H, Atsuta Y, Szer J, Kodera Y, Niederweiser D, Gratwohl A, Horowitz MM

Challenges and Opportunities for HSCT Outcome Registries; Perspective from International HSCT Registries Experts* *accepted by BMT March 7, 2014 as this re-port is going to print

WBMT Transplant Center and Recipi-ent Committee

Leemhuis T, Padley D, Keever-Taylor C, Nie-derwieser D, Teshima T, Lanza F, Cha-bannon C, Szabolcs P, Bazarbachi A, Koh, M

Minimal Requirements and Essential Features for Setting up a Stem Cell Processing Laboratory* *accepted in BMT March 13, 2014 as this re-

port is going to print

WBMT Graft Pro-cessing Committee

Published in 2013

Niederwieser D for the Worldwide Network for Blood and Marrow Transplantation

One Millionth Blood Stem Cell Trans-plant Marks Major Medical Milestone: International Cooperation Among Phy-sicians, Scientists Credited for Land-mark Achievement

Rev Hematol Mex 2013;14:84-85 WBMT

Gratwohl A, Baldomero H, Gratwohl M, Aljurf M, Bouzas L, Horowitz M, Kodera Y, Lipton J, Iida M, Pasquini M, Passweg J, Szer J, Madrigal A, Frauendorfer K, Niederwieser

Quantitative and qualitative differ-ences in use and trends of hematopoi-etic stem cell transplantation: a Global Observational Study.

Haematologica. 2013 Aug;98(8):1282-90. doi: 10.3324/haematol.2012.076349. [Epub 2013 Mar 18]

WBMT

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D

Author(s) Title Citation Credited to:

Halter JP, van Walraven SM, Worel N, Bengtsson M, Hägglund H, Nicoloso de Fa-veri G, Shaw BE, Schmidt AH, Fechter M, Madrigal A, Szer J, Aljurf MD, Weisdorf D, Horowitz MM, Greinix H, Niederwieser D, Gratwohl A, Kodera Y, Confer D

Allogeneic hematopoietic stem cell donation—standardized assessment of donor outcome data: A consensus statement from the Worldwide Net-work for Blood and Marrow Transplan-tation (WBMT)

Bone Marrow Transplant. 2013 48, 220–225; doi:10.1038/bmt.2012.119; [Epub 2012 July 09].

WBMT Donor Safety Committee

Published in 2010

Gratwohl G, Baldomero H, Aljurf M, Pas-quini M, Bouzas L, Yoshimi A, Szer J, Lipton L, Schwendener A, Gratwohl M, Frauen-dorfer K, Niederwieser D, Horowitz M, Kodera Y, for the Worldwide Network of Blood and Marrow Transplantation

Hematopoietic stem cell transplanta-tion; a global perspective

JAMA. 2010; 303(16):1617-1624. doi:10.1001/jama.2010.491.

WBMT

Published in 2009

Halter J, Kodera Y, Urbano Ispizua A, Greinix HT, Schmitz N, Favre G, Baldomero H, Nie-derwieser D, Apperley JF, and Gratwohl A, for the European Group for Blood and Mar-row Transplantation (EBMT) activity survey office

Severe events in donors after allogene-ic hematopoietic stem cell donation.

Haematologica 2009; 94:94-101. doi: 10.3324/haematol.13668

WBMT Donor Safety Committee

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APPENDIX H: TERMS AND ABBREVIATIONS

Term / Abbreviation Definition

AABB AABB; formerly known as American Association of Blood Banks

ABMTRR Australasian Bone Marrow Transplant Recipient Registry

AFBMT African Blood and Marrow Transplant Group

AHCTA Alliance for the Harmonization of Cellular Therapy Accreditation

APBMT Asia-Pacific Blood and Marrow Transplantation Group

ASBMT American Society for Blood and Marrow Transplantation

ASH American Society of Hematology

BIG V&S SARE Bologna Initiative for Global Vigilance and Surveillance of Adverse Reactions and Events

BM bone marrow

BMDW Bone Marrow Donors Worldwide

CB cord blood

CIBMTR Center for International Blood and Marrow Transplant Research

CME continuing medical education

CNT Italian National Transplant Centre

EBMT European Blood and Marrow Transplantation Group

EDQM European Directorate for the Quality of Medicines & HealthCare

EHA European Hematology Association

ESH European School of Haematology

FACT Foundation for Accreditation of Cellular Therapy

GODT Global Observatory on Donation and Transplantation

FAQs Frequently Asked Questions

GTCN global transplant center number

HPC human progenitor cells

HSCT hematopoietic stem cell transplantation

ICCBBA International Council for Commonality in Blood Banking Automation

ISBT International Society of Blood Transfusion

ISCT International Society of Cellular Therapy

LABMT Latin American Blood and Marrow Transplant Society

MCI MCI Suisse SA, a professional congress organizer

NGO Non-government Organization

NIHBT National Institute of Hematology and Bone Marrow Transplantation

NMDP National Marrow Donor Program

ONT Organización Nacional de Transplantes

PB peripheral blood

PBSC peripheral blood stem cells

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Term / Abbreviation Definition

SBMTO Sociedade Brasileira de Transplante de Medula Óssea

SOHO V&S Vigilance and Surveillance of Substances of Human Origin

TAS Transplant Activity Survey

UN United Nations

WBMT Worldwide Network for Blood and Marrow Transplantation

WHO World Health Organization

WMDA World Marrow Donor Association