EBMT NEWSLETTER | September 2015 | Volume 48 - Issue 3

EBMT
Important dates

On the occasion of the World Marrow Donor Day (www.worldmarrowdonorday.org), that will be celebrated on Saturday 19th of September, the EBMT would like to emphasize the establishment of the EBMT donor outcome database that enable to obtain robust data on donor safety and follow-up.

The increasing number of allogeneic HSCT has only become possible because of the ongoing willingness of so many related and unrelated donors to undergo a stem cell collection procedure. Ensuring donor safety and increasing the knowledge on donor outcome is an integral part of the allogeneic HSCT therapy, that is now further challenged by the introduction of new mobilizing agents (cell binding inhibitors (e.g. plerixafor), biosimilars of G-CSF) and the increasing use of hematopoietic cellular therapies including DLI. In order to get scientifically valid answers on donor outcome, it is of great importance that we all collect donor outcome data together on an international level.

The EBMT Donor Outcome Committee1 would like to inform that it is now possible to enter donor (related and unrelated) outcome data into the ProMISe database of EBMT Registry. Procedures are in place that allow the registration of donors even if the patient’s transplant has not been registered due, for example, to the patient being transplanted in a country not represented in the EBMT. The ProMISe database contains questions based on recommendations for a minimum data set for follow-up2.

Donor follow-up is already mandated by law in some European countries. The European Union (EU) prescribes in an EU Directive3 that any adverse event must be recorded and reviewed. Regulations by professional bodies e.g. FACT-JACIE4, WMDA5, require donor follow-up to be performed and donor outcome follow-up has also been included into the Guiding Principles of therapeutic cell and tissue donation of WHO, endorsed by the World Health Assembly in May 20106.

All persons involved in donor follow-up are invited to participate in reporting donor outcome data, in accordance to regulations in place in your country regarding the submission of this type of data.

The procedure for participating is as follows:
  1. Donor outcome data can be reported by:
    1. transplant centers / collection centers: related donor data
    2. unrelated donor registries/ collection centers / donor centers: unrelated donor data
  2. EBMT membership is needed; here you can apply to be a member
  3. Based on the minimum data set1, a manual for Data manager as well as the two following different forms are available on the EBMT Website (see link):
    – Report on donation procedures up to 30 days after donation
    – Long term follow up report form
    https://www.ebmt.org/Contents/Data-Management/Registrystructure/MED-ABdatacollectionforms/Pages/MED-AB-data-collection-forms.aspx#DonorOutcomeForms
If you need technical support, please contact registryhelpdesk@ebmt.org , for other questions please contact Isabelle Widmer, isabelle.widmer@blutspende.ch
On behalf of the members of the EBMT donor outcome committee,
Sincerely, yours
 
Joerg Halter
Chair of the EBMT Donor Outcome Committee


References
  1. https://www.ebmt.org/Contents/About-EBMT/Who-We-Are/Committees/Pages/Committees.aspx#DonorOutcomes
  2. 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. Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards technical requirements for the donation, procurement an testing of human tissues and cells. Annex IV, 1.3.6
    http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:038:0040:0052:EN:PDF
  4. FACT-JACIE International Standards for Hematopoietic Cellular Therapy, Product Collection, Processing, and Administration, Sixth Edition B6.3.10
  5. World Marrow Donor Association, International Standards for Unrelated Hematopoietic Progenitor Cell Donor Registries, Version January 1, 2014, Point 9
    https://www.wmda.info/images/pdf/WMDAStandards.pdf
  6. Who Guiding Principles on human cell, tissue and organ transplantation, WHO. Guiding Principle 10 http://www.who.int/transplantation/Guiding_PrinciplesTransplantation_WHA63.22en.pdf
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