Remuneration of donors for cell and gene therapies: an update on the principles and perspective of the World Marrow Donor Association.

The cell and gene therapy (CGT) sector has witnessed significant advancement over the past decade, the inception of advanced therapy medicinal products (ATMPs) being one of the most transformational. ATMPs treat serious medical conditions, in some cases providing curative therapy for seriously ill patients. There is interest in pivoting the ATMP development from autologous based treatments to allogenic, to offer faster and greater patient access that should ultimately reduce treatment costs. Consequently, starting material from allogenic donors is required, igniting ethical issues associated with financial gains and donor remuneration within CGT. The World Marrow Donor Association (WMDA) established the Cellular Therapy Committee to identify the role WMDA can play in safeguarding donors and patients in the CGT field. Here we review key ethical principles in relation to donating cellular material for the CGT field. We present the updated statement from WMDA on donor remuneration, which supports non-remuneration as the best way to ensure the safety and well-being of donors and patients alike. This is in line with the fundamental objective of the WMDA to maintain the health and safety of volunteer donors while ensuring high-quality stem cell products are available for all patients. We acknowledge that the CGT field is evolving at a rapid pace and there will be a need to review this position as new practices and applications come to pass.

Audit of donor centre: guidelines by the World Marrow Donor Association Quality and Regulation Working Group.

According to the Standards of the World Marrow Donor Association (WMDA) 2020 [1] unrelated stem cell donor registries are responsible for compliance of their donor centres with these Standards. To ensure high stem cell product quality and high standards for safety and satisfaction of voluntary unrelated stem cell donors, we present here guidelines for audits of donor centres (DC) that can be used by new and established donor registries. They have been developed for registries relying on independent national or international DCs for the recruitment and management of Unrelated Donors (UD) for verification typing (VT)/extended tying (ET), work up processes and Hemopoietic Progenitor Cell (HPC) donation. The main goal of these guidelines is to support registries in verifying and auditing their affiliated DCs to ensure they are compliant with the WMDA Standards, as well as WMDA recommendations. We define the general requirements and recommendations for collaboration with the DC and guidelines to manage the UD, step by step from recruitment to follow-up. We also provide a checklist, intended to serve as a resource for auditors performing an audit at a DC.