Facilitating the ethical sourcing of donor hematopoietic stem cells for cell and gene therapy research and development.

ABSTRACT

Aim: Unrelated stem cell donor registries (DRs) are increasingly engaging in the field of cell and gene therapy (CGT). This study aims to explore the values, concerns, needs and expectations of donors and members of the public on donating hematopoietic stem cells (HSCs) for CGT.Methods: Seven focus groups were conducted in 2019 with members of the public, prospective donors and donors on the Anthony Nolan DR in the UK.Results: Participants expressed concerns over increased frequency of donation and incidental findings and required more information on the type of research including the purpose and possible outcomes.Conclusion: Addressing donors' concerns, needs and expectations on donating cellular materials for CGT research and development is essential to maintaining the highest standards for donor care and safety within this rapidly emerging field.

This study aims to explore the values, concerns, needs and expectations of people who donate, or consider donating, their stem cells (cells that can develop into many different types of cells) for research that could lead to new medical treatments. We focused on the thoughts of these donors about providing their cells for use in cell and gene therapy (CGT) research, a field that is rapidly advancing but still forming its rules and ethical guidelines. In 2019, we conducted seven focus groups (FGs) with a total of 73 people in the UK. This included individuals who are registered as potential stem cell donors on the Anthony Nolan unrelated stem cell donor register (DR), those who have already donated stem cells and members of the general public. We explored their thoughts about their donated cells being used for research to develop new therapies rather than for direct treatment of patients. Questions during the FGs touched on topics such as the roles of various organizations in managing donated cells, the commercial use of these cells and where responsibilities lie in ensuring ethical practices. Participants expressed a strong desire for openness and clear communication regarding how their donated cells are used in research. They wanted to ensure that any use of their cells aligns with their personal values and the ethical standards of the organizations handling the donations. Participants expected DRs like Anthony Nolan to safeguard their interests and the ethical use of their cells. This study highlights that while donors are generally willing to contribute to advancements in CGT research, they need clear, understandable information about how their donations are used. This is crucial for maintaining their trust and willingness to donate. Overall, this study underscores the importance of ethical practices and donor engagement in the growing field of CGT, ensuring that donor contributions are respected and used responsibly.