Workshop “Current and future challenges in voluntary bone marrow donors in Spain”

On September 26, Barcelona hosted the workshop “Current and Future Challenges in Voluntary Bone Marrow Donors in Spain,” organized by the Josep Carreras Foundation against Leukaemia and the Spanish Registry of Bone Marrow Donors (REDMO), with the collaboration of the National Transplant Organization (ONT) and the Spanish Society of Blood Transfusion and Cellular Therapy (SETS). The event brought together professionals involved in the promotion, collection, management, and quality assurance of voluntary hematopoietic stem cell donors.

The main objective of the workshop was to identify challenges and define priority lines of action for the coming years, based on the clinical, technical, and regulatory experience shared by the speakers. The discussions in each session led to proposals for procedures and development programs that will serve as the foundation for progress toward a more homogeneous, safe national framework aligned with the forthcoming European SoHO Regulation (EU 2024/1938) and the new European requirements for donor quality and protection.

Key lines of work discussed during the workshop
Based on the presentations and discussions among participants, several priority lines of work were identified to improve the management, quality, and safety of voluntary hematopoietic stem cell donors.

• Rejuvenating the donor registry
  According to recent publications on donor selection, transplants from younger donors (under 35 years old) are associated with better clinical outcomes. For this reason, participants discussed the need to incorporate more young people, especially men, to maintain the efficiency and sustainability of REDMO in the coming years.
• Use of Plerixafor
  In peripheral blood collections, cases of mobilization failure with growth factors are rare (around 5%), but in such cases, the use of Plerixafor can help achieve the required cell count when G-CSF alone is insufficient. Currently, the use of this drug is limited to compassionate use within hospitals, which hinders standardization. Therefore, the creation of a national protocol was proposed to allow its regular and safe use, moving beyond its restriction to exceptional cases.
• Training in bone marrow extraction
  Although bone marrow collection represents a small proportion of procedures, it remains essential for certain conditions, particularly in pediatric or non-malignant patients. The creation of a training system for medical and nursing teams was proposed to ensure generational replacement and maintain technical competence in this procedure. The program under development would guarantee at least one team per autonomous community, with the ability to move between centers according to clinical needs.
• Labeling of cellular products
  Safety and traceability largely depend on correct and consistent labeling. Currently, differences among centers may hinder uniformity. A common labeling model compatible with international standards (ISBT128, SEC, FACT-JACIE, and WMDA) was proposed to ensure complete and safe traceability across all collection and processing centers.
• Quality certification of donor centers
  With the publication of the new European SoHO Regulation, all centers involved in donation will need to comply with stricter quality and safety requirements. In this context, the new CAT standard was presented, developed by the CAT Foundation in collaboration with REDMO and ONT, which will allow donor centers to be accredited according to WMDA international criteria.
• The future of the SoHO donor registry
  The new European framework broadens the role of voluntary donors beyond hematopoietic transplantation, opening the door to their participation in advanced therapies and biomedical innovation projects. This evolution will require new models of informed consent and more comprehensive ethical and regulatory oversight to protect donors’ rights and ensure the responsible use of their cells.

This workshop marked an important step forward in defining the strategic lines that will guide the joint work of REDMO, ONT, and regional blood and tissue banks in the coming years.
The resulting procedures will serve as the basis for developing protocols, guidelines, and training programs that strengthen donor safety and the quality of cellular products within the new European SoHO framework (EU 2024/1938).

🔗 More information on the SETS website