Aim: To explore prospective donors' attitudes and perceptions toward donating hematopoietic stem cells (HSCs) for novel treatments research and development (R&D). Methods: A survey was launched by Anthony Nolan (AN) to assess prospective donors' willingness to donate HSCs for novel therapies R&D, and their degree of comfort with the AN collaborating with and receiving payment from external organizations. Results: Most participants (87%) were willing to donate for novel treatment R&D and were comfortable with AN collaborating with external organizations and receiving payment (91% and 80%, respectively). Conclusion: Results reveal an overall positive response toward donating HSCs for R&D. These findings can support stakeholders and policymakers in outlining donation practices that uphold donors' safety and welfare.

Plain language summary

Recent interest in the development of cell-based novel treatments using stem cells from healthy donors as opposed to patients' own stem cells may place pressure on stem cell donor registries to adapt and provide donor stem cells to the cell and gene industry. Since stem cell donor registries were originally established to connect patients in need of stem cell transplantation with matched willing stem cell donors, this shift in practice might result in several implications. Therefore, Anthony Nolan (AN), an unrelated stem cell donor registry in the UK, launched a survey to explore the willingness of potential donors to donate stem cells for novel treatment research and development (R&D). The results show that most participants (87%) would be willing to donate stem cells for novel treatment research and development. Most participants were comfortable with AN collaborating with external organizations (91%) and receiving payment from these organizations (80%). Additionally, some participants provided written responses that explained their answers to the questions in the survey. While some participants had positive views on collaborations with external establishments, others had apprehensions over their donations leading to profiteering. Moreover, participants had concerns over their privacy, especially if external collaborations with pharmaceutical companies were to take place. Informed consent and transparency over the nature of collaborations could relieve some of the above-mentioned concerns. These findings can support stakeholders and policymakers in outlining donation practices that uphold donors' safety and welfare.

Tweetable abstract

The cell and gene industry is becoming increasingly dependent on donors providing stem cells for the development of novel therapies. This study shows an overall positive response by prospective donors toward donating stem cells for novel treatments research and development.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

References

1. European Medicines Agency. Advanced therapy medicinal products: overview (2021). www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview#stem-cells-section
Google Scholar
2. US Food and Drug Administration. Approved Cellular and Gene Therapy Products (2022). www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
Google Scholar
3. De Luca M, Aiuti A, Cossu G, Parmar M, Pellegrini G, Robey PG. Advances in stem cell research and therapeutic development. Nature Cell Biology 21, 801–811 (2019).
MedlineGoogle Scholar
4. Medicine. AfR. Regenerative Medicine: The Pipeline Momentum Builds (2022).
Google Scholar
5. Cell and Gene Therapy Catapult. The Cell and Gene Therapy Catapult UK clinical trials database (2021). https://ct.catapult.org.uk/clinical-trials-database
Google Scholar
6. Karantalis V, Schulman IH, Balkan W, Hare JM. Allogeneic cell therapy: a new paradigm in therapeutics. Circ. Res. 116(1), 12–15 (2015).
Medline CASGoogle Scholar
7. Rahm AK, Wrenn M, Carroll NM, Feigelson HS. Biobanking for research: a survey of patient population attitudes and understanding. J. Community Genet. 4(4), 445–450 (2013).
MedlineGoogle Scholar
8. Dasgupta I, Bollinger J, Mathews DJ, Neumann NM, Rattani A, Sugarman J. Patients' attitudes toward the donation of biological materials for the derivation of induced pluripotent stem cells. Cell Stem Cell 14(1), 9–12 (2014). • Provides insight into patient's attitudes and concerns towards donating biospecimens for the development of cellular therapies such as pluripotent stem cells.
Medline CASGoogle Scholar
9. Master Z, Crowley AP, Smith C, Wigle D, Terzic A, Sharp RR. Stem cell preservation for regenerative therapies: ethical and governance considerations for the health care sector. NPJ Regen. Med. 5(1), 23 (2020).
MedlineGoogle Scholar
10. Caulfield T, Burningham S, Joly Y, Master Z, Shabani M, Borry P et al. A review of the key issues associated with the commercialization of biobanks. J. Law Biosci. 1(1), 94–110 (2014).
MedlineGoogle Scholar
11. Dive L, Critchley C, Otlowski M, Mason P, Wiersma M, Light E et al. Public trust and global biobank networks. BMC Med. Ethics 21(1), 73 (2020). • Discusses how biobanks are increasingly facing pressure to commercialize and translate their work, leading to increasing expectations for partnerships with the commercial industry. This can be extended to stem cell donor registries in the context of advancements in the cell and gene industry.
MedlineGoogle Scholar
12. von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int. J. Surg. 12(12), 1495–1499 (2014).
MedlineGoogle Scholar
13. Liao G, Gilmore K, Steed A, Elmoazzen H, Allan DS. Willingness of volunteers from Canadian Blood Service's Stem Cell Registry to donate blood, marrow, and other tissues for regenerative therapy. Transfusion 60(3), 582–587 (2020). •• Only other study in the literature directly assessing HSCs donors willingness to donate for regenerative therapy.
MedlineGoogle Scholar
14. Baía I, de Freitas C, Samorinha C, Provoost V, Silva S. Dual consent? Donors' and recipients' views about involvement in decision-making on the use of embryos created by gamete donation in research. BMC Medical Ethics 20(1), 90 (2019).
Medline CASGoogle Scholar
15. Hamad L, Anthias C, Machin L. How do we forecast tomorrow's transfusion: the future of hematopoietic stem cell donation. Transfus. Clin. Biol. 30(1), 52–55 (2023). •• Provides insight into HSCs donors perceptions surrounding donation aimed at multiple recipients and donations aimed at treating conditions of varying severity.
MedlineGoogle Scholar
16. Li EW, Lee A, Vaseghi-Shanjani M, Anagnostopoulos A, Jagelaviciute G, Kum E et al. Multimedia resources to support the recruitment of committed hematopoietic stem cell donors: perspectives of the most-needed donors. Transfusion 61(1), 274–285 (2021).
MedlineGoogle Scholar
17. Kum E, Jagelaviciute G, Li E, Williams K, Thyagu S, Fingrut W. Donor-Recipient Story in Allogeneic Hematopoietic Stem Cell Transplantation. Curr. Oncol. 28(1), 689–692 (2021).
MedlineGoogle Scholar
18. Critchley C, Nicol D. Understanding the impact of commercialization on public support for science: is it about the funding source or the organization conducting research. Public Understanding of Science 20, 347–366 (2011).
MedlineGoogle Scholar
19. Christine R. Critchley, Gordana Bruce, Matthew Farrugia. The Impact of Commercialisation on Public Perceptions of Stem Cell Research: Exploring Differences Across the Use of Induced Pluripotent Cells, Human and Animal Embryos. Stem Cell Reviews and Reports 9, 541–554 (2013).
MedlineGoogle Scholar
20. Ozieranski P, Csanadi M, Rickard E, Mulinari S. Under-reported relationship: a comparative study of pharmaceutical industry and patient organisation payment disclosures in the UK (2012-2016). BMJ Open 10(9), e037351 (2020).
MedlineGoogle Scholar
21. Shabani M, Borry P. Rules for processing genetic data for research purposes in view of the new EU General Data Protection Regulation. Eur. J. Hum. Genet. 26(2), 149–156 (2018).
MedlineGoogle Scholar
22. Billen A, Madrigal JA, Scior K, Shaw BE, Strydom A. Donation of peripheral blood stem cells to unrelated strangers: a thematic analysis. PLOS ONE 12(10), e0186438 (2017).
MedlineGoogle Scholar
23. Garcia MC, Chapman JR, Shaw PJ et al. Motivations, experiences, and perspectives of bone marrow and peripheral blood stem cell donors: thematic synthesis of qualitative studies. Biol. Blood Marrow Transplant 19(7), 1046–1058 (2013).
MedlineGoogle Scholar
24. Dimond R, Machin L, Frith L. Editorial: towards a sociology of donation. Sociol. Health Illn. 41(3), 549–552 (2019). • Discusses the fluctuating boundary between donation and exchange, and how donation for research can represent an ongoing relationship between the researcher and the participant.
MedlineGoogle Scholar
25. The Association of the British Pharmaceutical Industry. New research reveals attitudes to pharmaceutical industry (2021).
Google Scholar
26. Qasim W. Allogeneic CAR T cell therapies for leukemia. Am. J. Hematol. 94(S1), S50–S54 (2019).
Medline CASGoogle Scholar
27. Depil S, Duchateau P, Grupp SA, Mufti G, Poirot L. ‘Off-the-shelf’ allogeneic CAR T cells: development and challenges. Nat. Rev. Drug Discov. 19(3), 185–199 (2020).
Medline CASGoogle Scholar
28. Johansen KA, Schneider JF, McCaffree MA, Woods GL. Council on S, Public Health AMA. Efforts of the United States' National Marrow Donor Program and Registry to improve utilization and representation of minority donors. Transfus. Med. 18(4), 250–259 (2008).
Medline CASGoogle Scholar
29. Nunes K, Aguiar VRC, Silva M, Sena AC, de Oliveira DCM, Dinardo CL et al. How Ancestry Influences the Chances of Finding Unrelated Donors: An Investigation in Admixed Brazilians. Front Immunol. 11, 584950 (2020).
Medline CASGoogle Scholar
30. Gragert L, Eapen M, Williams E, Freeman J, Spellman S, Baitty R et al. HLA match likelihoods for hematopoietic stem-cell grafts in the U.S. registry. N. Engl. J. Med. 371(4), 339–348 (2014).
Medline CASGoogle Scholar

Vol. 18, No. 4

Supplemental Materials

Metrics

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History

Received 21 November 2022

Accepted 16 February 2023

Published online 9 March 2023

Published in print April 2023

Information

Keywords

Author contributions

L Hamad: Data analysis, writing of original draft. C Anthias: Conceptualization, methodology, data collection, analysis revision, review and editing of pre-submission draft. D Gibson: Review and editing of pre-submission draft. A O'Leary: Conceptualization, methodology, data collection, review and editing of pre-submission draft. L Machin: Conceptualization, methodology, data collection, review and editing of pre-submission draft.

Acknowledgments

We wish to acknowledge the generous financial support from P Welch and Friends of Lancaster University in America that has funded L Hamad's research assistant role whilst writing this paper.

Financial & competing interests disclosure

C Anthias is the donor care physician at Anthony Nolan. D Gibson is the director of cell and gene therapy services at Anthony Nolan. A O'Leary is the director of donor and transplantation services at Anthony Nolan. L Machin is the past chairperson and current member of the institutional review board (IRB) at Anthony Nolan. L Machin received funding for this project from Anthony Nolan (https://www.anthonynolan.org/) under grant number: MED7070.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval 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.

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