Review of the Med-A for HSCT

During the past two years the EBMT has been involved in a major review of the Med-A data collection form for haematopoietic stem cell transplantation (HSCT). This has been fuelled by the recognition by all EBMT working parties that the HSCT Med-A was too narrow and that it was advisable for more information to be requested in order to better screen patients for studies. The feeling was particularly strong when it related to items associated with HLA and conditioning.

Process and outcome of the review

The CIBMTR was also engaged in the review of their own version of the Med-A, the TED. Even if the motivation behind reviews of the data collection forms was not identical for both organisations, there was sufficient overlap to allow us to work together and this is what we have done. We have engaged in a process through which we shared information, engaged in discussions face to face, by e-mail and by phone and, overall, spent a lot of time e-mailing and reading each other's versions of data collection forms and definitions. The work was worthwhile and a few months ago the final version of the HSCT Med-A was approved by the EBMT Board.

The main changes to the HSCT Med-A involve, first, the addition of more detailed questions relating to the preparative regimen and GvHD prophylaxis, and, second, a different and more detailed way of collecting information on HLA matching.

EBMT facilitation of data transfer to the CIBMTR

The CIBMTR TED has more items than the Med-A due mostly to regulatory requirements imposed by the USA government, but also to requirements imposed by the CIBMTR on their research centres. The EBMT felt that making it mandatory to report these additional items by incorporating them in the body of the Med-A increased too much the burden of reporting for EBMT centres. However, in our continuous program to support those EBMT centres that do want to provide these data to the CIBMTR, all of these items will be incorporated into the Med-A as an Appendix. In this way, EBMT centres can comply with both organisations by filling only one form and submitting the data to the EBMT. The EBMT, as usual, will forward the data to the CIBMTR for those centres that request us to do so. If you are one of those centres, please make sure that you have sent us a "Permission to share data with the CIBMTR", which you can find at this address:
http://www.ebmt.org/4Registry/registry2.html#cibmtr

The form must be signed by the Principal investigator of your centre. Centres will no longer be able to request that the data be forwarded to the CIBMTR by ticking a box in the Med-A form.

Implementation

The revised Med-A, including the Med-A Appendix, is in the process of being incorporated into the EBMT database and adequate navigation will be provided so that centres can enter either the main Med-A by itself, or the Med-A plus the Med-A Appendix through ProMISe. If your centre does not use ProMISe, the paper version of the Med-A, and Med-A Appendix if applicable, should be sent to the EBMT Data Office in Paris or to your National Registry, as usual. Please do not send us the TED forms; the navigation for the TED is not available in the EBMT database and it is unnecessary since all items that exist in the TED, also exist in the Med-A plus Med-A Appendix. We expect to have the revised Med-A in place during the summer. We cannot provide now an exact date, but we will email all Principal Investigators and Data Managers as soon as the revised form is available both in paper and as implementation in the EBMT database. For this reason, please check that the email addresses of the relevant members of staff in your centre are up-to-date in the membership list which you can access on www.ebmt.org.

Conclusion

We hope you will approve of the changes we have made to the Med-A. Positive feedback has already reached us from several National societies and individual centres and we look forward to using the data collected through the revised forms to further the aims of the EBMT.

M Carmen Ruiz de Elvira
Head of the Registry

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Cell therapy Registry (CTR)

A new registry has been opened in the EBMT database. The Cell Therapy Registry (CTR) aims to collect data on fetal or adult stem cells, or progenitor cells used for treatment other than haematopoietic stem cell transplantation or donor lymphocyte infusion, as well as data on the clinical characteristics and outcome of the patients. Data will be collected on characteristics of the cell graft, in or ex vivo cell manipulation and the cell origin (autologous versus allogeneic). Data will include details on patients treated with mesenchymal cells, for instance, to enhance haematopoietic engraftment, for prophylaxis and treatment of GvHD. The registry will also include data on patients treated by other disciplines for neurologic, rheumatologic, cardiac and inflammatory bowel diseases and tissue regeneration. The registry will contain a MED A form, common for all types of cell therapies, collecting basic data and allowing detailed retrospective data collection. The registry will eventually evolve to include MED B forms, specific for disease categories (rheumatology, neurology, haematology, tissue engineering, etc.) and, in some cases, also specific for the cell graft, such as in MSC transplantation.

The field of cell therapy is rapidly expanding. It includes cell preparations defined by various criteria and may be applicable to patients suffering from various disorders. To date, clinical experience, both regarding the positive effects of such treatments and the risk of possible side effects is very limited. The CTR aims to collect data on patients treated with novel therapies for retrospective data analyses and as a basis for future collaborative efforts.

Katarina Leblanc & Willem Fibbe
Co-Chairs of the Developmental Committee