https://orcid.org/0000-0001-8511-8080
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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.
Plain language summary
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.
The first approval of allogeneic T-cell immunotherapy in late 2022 highlights a significant advancement in cell and gene therapy (CGT), using donor cells to create standardized treatments accessible off-the-shelf.
This breakthrough has led to a greater reliance on unrelated stem cell donor registries (DRs) for providing HSCs cells for research and manufacturing of these therapies.
As DRs expand their roles in CGT, several implications might arise, including but not limited to the safe, ethical sourcing of donor hematopoietic stem cells (HSCs) and other cellular materials.
In collaboration with Anthony Nolan, a UK unrelated stem cell DR, we conducted focus groups with members of the public and donors from the AN registry in London to explore their views on donating HSCs for CGT.
Participants trusted DRs like Anthony Nolan to maintain ethical standards in collaborations. However, they were concerned about the moral and legal responsibilities of DRs when donor cells are used in commercial research.
Participants highlighted the importance of DRs engaging donors through clear communication about how donated cells are used in research.
The potential increased frequency of donation requests from commercial partnerships raised concerns about donor safety and the ethical implications of repeated donations.
Some donors expressed anxiety about the possibility that researchers might discover incidental findings in the donated cells during processing which could impact the donors personally.
The findings of this study underline the necessity for DRs engaging in CGT to develop policies that reflect donor values and ensure ethical practices. This is crucial as CGT technologies evolve and new ethical challenges emerge.
Supplemental material
Supplemental data for this article can be accessed at https://doi.org/10.1080/17460751.2024.2357930
Acknowledgments
We wish to acknowledge the generous financial support from P Welch, Friends of Lancaster University in America (FLUA) and Lancaster University that has funded L Hamad's research assistant role while writing this paper.
Author contributions
L Hamad: data analysis, writing of original draft, review and editing of pre-submission draft. C Anthias: conceptualization, methodology, data collection, analysis revision, review and editing of pre-submission draft. L Machin: conceptualization, methodology, data collection, review and editing of pre-submission draft. CK Chekar: review and editing of pre-submission draft.
Financial disclosure
L Machin received funding for this project from Anthony Nolan (https://www.anthonynolan.org/) under grant number: MED7070. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Competing interests disclosure
C Anthias: donor care physician at Anthony Nolan. L Machin: past chairperson and current member of the institutional review board (IRB) at Anthony Nolan. L Hamad and CK Chekar: declare no conflict of interest. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing disclosure
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The authors state that they have obtained appropriate institutional review board approval from the Faculty of Health and Medicine at Lancaster University (#FHMREC17102) and/or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations.
In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.
Data availability statement
Data is not available due to ethical restrictions. Due to the nature of this study, participants were recruited on the basis of informed consent and did not agree for their data to be shared publicly. Permission was not requested to share data when submitting the ethical approval form because of the commercial sensitivity around the aims and objectives of the wider research study and the resulting data analysis.