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

Safety of living donors is critical to the success of blood, tissue and organ transplantation. Structured and robust vigilance and surveillance systems exist as part of some national entities, but historically no global systems are in place to ensure conformity, harmonisation and the recognition of rare adverse events (AEs). The World Health Assembly has recently resolved to require AE/reaction (AE/R) reporting both nationally and globally. The World Marrow Donor Association (WMDA) is an international organisation promoting the safety of unrelated donors and progenitor cell products for use in haematopoietic progenitor cell (HPC) transplantation. To address this issue, we established a system for collecting, collating, analysing, distributing and reacting to serious adverse events and reactions (SAE/R) in unrelated HPC donors. The WMDA successfully instituted this reporting system with 203 SAE/R reported in 2011. The committee generated two rapid reports, reacting to specific SAE/R, resulting in practice changing policies. The system has a robust governance structure, formal feedback to the WMDA membership and transparent information flows to other agencies, specialist physicians and transplant programs and the general public.

International exchange of cord blood units: the registry aspects.

The international exchange of cord blood units (CBUs) for transplantation has brought new challenges to the stem cell donor registries involved in the exchange of BM and PBSCs. The unique properties of cord blood cells and differences in the search processes between CBUs and adult unrelated donors has required registries responsible for cord blood bank (CBB) networks to review their current practices and to develop new processes to accommodate for the provision of CBUs. This paper describes the aims and activities of the World Marrow Donor Association (WMDA) Cord Blood Working Group (CBWG) which was established in 2007 to gather and exchange information about cord blood registry needs and activities, and to develop guidelines to support and promote safe effective international exchange of unrelated CBUs for transplantation.

Monitoring the international use of unrelated donors for transplantation: the WMDA annual reports.

The World Marrow Donor Association Annual Reports describe the current status of the use of unrelated hematopoietic cell products worldwide. In 2008, almost 1.7 million individuals were recruited into unrelated stem cell donor registries and almost 78 000 cord blood units were added to the inventory increasing the total number of available stem cell donors worldwide to over 14 million. In 2008, there were 10 481 adult stem cell donations (3221 BM and 7260 PBSC donations) provided from stem cell donor registries in 38 countries. In 2008, 3529 cord blood products were provided from 21 countries. Although the number of BM donations has been stable over the past 10 years, donations of PBSCs and umbilical cord blood are increasing.

Standards, regulations and accreditation for registries involved in the worldwide exchange of hematopoietic stem cell donors and products.

The World Marrow Donor Association (WMDA) is working closely with other international organizations working in cellular therapy such as the Worldwide Network for Blood and Marrow Transplantation (WBMT) to develop and maintain global recommendations and requirements for a standardized practice. WMDA launched its registry accreditation program in September 2003. Since then, 17 of the 71 hematopoietic stem cell donor registries worldwide have been accredited. These accredited registries list over 80% of the hematopoietic stem cell donors and umbilical cord blood units listed in the database of BM Donors Worldwide. The goal of the WMDA Standards and Accreditation process is to protect donors while serving the needs of patients who are urgently seeking histocompatible donors in worldwide searches. These activities address the increasing governmental regulations regarding the quality and safety of stem cells collected internationally for national patients.