Serious Adverse Events in Hematopoietic Stem Cell Donors: A Literature Review

This paper reviews the available science literature to survey serious adverse events (SAEs) in hematopoietic stem cell donors (HSC). The data obtained and summarized provide a rich resource to inform potential donors about possible risks associated with different methods of HSC collection and additionally contribute to the development of effective approaches for the prevention of complications. The analysis suggests that the incidence of SAEs in bone marrow donors is 0.04–2.4 %. The most ubiquitous SAE are infectious, cardiovascular and cerebrovascular complications as well as mechanical damage. The SAE rate in peripheral blood stem cell collection is 0.1–1.1 %. The most common complications include infections, acute systemic toxicity during cell mobilization and collection, cardiovascular and cerebrovascular complications. The incidence of malignant neoplasms in HSC donors is not higher than in the general population.

• Elena Vitalevna Kuzmich Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya ul., Saint Petersburg, Russian Federation, 191024 https://orcid.org/0000-0003-0489-1763 (unauthenticated)
• I.E. Pavlova Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya ul., Saint Petersburg, Russian Federation, 191024 https://orcid.org/0000-0001-7756-4902 (unauthenticated)
• T.V. Glazanova Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya ul., Saint Petersburg, Russian Federation, 191024 https://orcid.org/0000-0002-1022-8127 (unauthenticated)
• L.N. Bubnova Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya ul., Saint Petersburg, Russian Federation, 191024 https://orcid.org/0000-0002-6690-3742 (unauthenticated)

1. Passweg JR, Baldomero H, Atlija M, et al. The 2023 EBMT report on hematopoietic cell transplantation and cellular therapies. Increased use of allogeneic HCT for myeloid malignancies and of CAR-T at the expense of autologous HCT. Bone Marrow Transplant. 2025;60(4):519–28. doi: 10.1038/s41409-025-02524-2. DOI: https://doi.org/10.1038/s41409-025-02524-2
2. Spellman SR, Xu K, Oloyede T, et al. Current Activity Trends and Outcomes in Hematopoietic Cell Transplantation and Cellular Therapy — A Report from the CIBMTR. Transplant Cell Ther. 2025;31(8):505–32. doi: 10.1016/j.jtct.2025.05.014. DOI: https://doi.org/10.1016/j.jtct.2025.09.001
3. WMDA Global Trends Report 2024. Available from: https://wmda.info/storage/2025/08/30072025-GTR-2024-Summary-Slides-gecomprimeerd.pdf (accessed 01.10.2025).
4. Favre G, Beksac M, Bacigalupo A, et al. Differences between graft product and donor side effects following bone marrow or stem cell donation. Bone Marrow Transplant. 2003;32(9):873–80. doi: 10.1038/sj.bmt.1704245. DOI: https://doi.org/10.1038/sj.bmt.1704245
5. Horowitz MM, Confer DL. Evaluation of Hematopoietic Stem Cell Donors. Hematology Am Soc Hematol Educ Program. 2005:469–75. doi: 10.1182/asheducation-2005.1.469. DOI: https://doi.org/10.1182/asheducation-2005.1.469
6. Nuamah NM, Goker H, Kilic YA, et al. Spontaneous splenic rupture in a healthy allogeneic donor of peripheral-blood stem cell following the administration of granulocyte colony-stimulating factor (G-CSF). A case report and review of the literature. Haematologica. 2006;91(5 Suppl):ECR08.
7. Yoshida I, Matsuo K, Teshima T, et al. Transient respiratory disturbance by granulocyte-colony-stimulating factor administration in healthy donors of allogeneic peripheral blood progenitor cell transplantation. Transfusion. 2006;46(2):186–92. doi: 10.1111/j.1537-2995.2006.00700.x. DOI: https://doi.org/10.1111/j.1537-2995.2006.00700.x
8. Bennett CL, Evens AM, Andritsos LA, et al. Haematological malignancies developing in previously healthy individuals who received haematopoietic growth factors: report from the Research on Adverse Drug Events and Reports (RADAR) project. Br J Haematol. 2006;135(5):642–50. doi: 10.1111/j.1365-2141.2006.06312.x. DOI: https://doi.org/10.1111/j.1365-2141.2006.06312.x
9. Anderlini P, Champlin RE. Biologic and molecular effects of granulocyte colony-stimulating factor in healthy individuals: recent findings and current challenges. Blood. 2008;111(4):1767–72. doi: 10.1182/blood-2007-07-097543. DOI: https://doi.org/10.1182/blood-2007-07-097543
10. Halter J, Kodera Y, Urbano Ispizua A, et al. Severe events in donors after allogeneic hematopoietic stem cell donation. Haematologica. 2009;94(1):94–101. doi: 10.3324/haematol.13668. DOI: https://doi.org/10.3324/haematol.13668
11. Miller JP, Perry EH, Price TH, et al. Recovery and safety profiles of marrow and PBSC donors: experience of the National Marrow Donor Program. Biol Blood Marrow Transplant. 2008;4(9):29–36. doi: 10.1016/j.bbmt.2008.05.018. DOI: https://doi.org/10.1016/j.bbmt.2008.05.018
12. Hölig K, Kramer M, Kroschinsky F, et al. Safety and efficacy of hematopoietic stem cell collection from mobilized peripheral blood in unrelated volunteers: 12 years of single-center experience in 3928 donors. Blood. 2009;114(18):3757–62. doi: 10.1182/blood-2009-04-218651. DOI: https://doi.org/10.1182/blood-2009-04-218651
13. Pulsipher MA, Chitphakdithai P, Logan BR, et al. Lower risk for serious adverse events and no increased risk for cancer after PBSC vs BM donation. Blood. 2014;123(23):3655–63. doi: 10.1182/blood-2013-12-542464. DOI: https://doi.org/10.1182/blood-2013-12-542464
14. Pahnke S, Larfors G, Axdorph-Nygell U, et al. Short-Term Side Effects and Attitudes Towards Second Donation: A Comparison of Related and Unrelated Haematopoietic Stem Cell Donors. J Clin Apher. 2018;33(3):226–35. doi: 10.1002/jca.21576. DOI: https://doi.org/10.1002/jca.21576
15. Pahnke S, Nygell UA, Johansson JE, et al. Cancer incidence in healthy Swedish peripheral blood stem cell donors. Bone Marrow Transplant. 2022;57(5):795–802. doi: 10.1038/s41409-022-01617-6. DOI: https://doi.org/10.1038/s41409-022-01617-6
16. Kisch AM, Winterling J, Hägglund H, et al. Hematopoietic Stem Cell Donors’ Experiences of Information and Side-Effects During the First Year After Donation — A Swedish National Study. J Clin Apher. 2025;40(4):e70050. doi: 10.1002/jca.70050. DOI: https://doi.org/10.1002/jca.70050
17. Давлятханова Е.И., Герова О.А., Андрюшкина А.В. и др. Анализ побочных симптомов при мобилизации гемопоэтических стволовых клеток с помощью гранулоцитарного колониестимулирующего фактора у неродственных доноров костного мозга. Вестник гематологии. 2022;18(2):49–50. [Davlyatkhanova E.I., Gerova O.A., Andryushkina A.V, et al. Analysis of the side effects during mobilization of hematopoietic stem cells using granulocyte colony-stimulating factor in unrelated bone marrow donors. Vestnik gematologii. 2022;18(2):49–50. (In Russ)]
18. Minaeva NV, Zorina NA, Lagunova MV, et al. Structure of adverse events in harvesting hematopoietic stem cell and bone marrow from unrelated donors. Cell Ther Transplant. 2024;13(3):208–10.
19. Styczynski J, Balduzzi A, Gil L, et al. Risk of complications during hematopoietic stem cell collection in pediatric sibling donors: a prospective European Group for Blood and Marrow Transplantation Pediatric Diseases Working Party study. Blood. 2012;119(12):2935–42. doi: 10.1182/blood-2011-04-349688. DOI: https://doi.org/10.1182/blood-2011-04-349688
20. Kodera Y, Yamamoto K, Kato S, et al. Safety and Risk of Allogeneic Peripheral Blood Stem Cell Donation: The Comprehensive Report of Nation-Wide Consecutively Pre-Registered 3,264 Family Donor Survey In 10 years Project by Japan Society for Hematopoietic Cell Transplantation. Bone Marrow Transplant. 2014;49(2):195–200. doi: 10.1038/bmt.2013.147. DOI: https://doi.org/10.1038/bmt.2013.147
21. Yanagisawa R, Hirakawa T, Doki N, et al. Severe short‑term adverse events in related bone marrow or peripheral blood stem cell donors. Int J Hematol. 2023;117(3):421–7. doi: 10.1007/s12185-022-03489-4. DOI: https://doi.org/10.1007/s12185-022-03489-4
22. World Marrow Donor Association. Total Number of Donors and Cord blood units. Available from: https://statistics.wmda.info/ (accessed 01.10.2025).
23. World Marrow Donor Association (WMDA) international standards unrelated haematopoietic stem cell donor registries. Available from: https://wmda.info/storage/2024/01/2024-WMDA-Stnds_20240101-final.pdf (accessed 01.10.2025).
24. Jöris M, Pustjens E, Mengling T, et al. New global reporting system for serious (product) events and adverse reactions in hematopoietic stem cell donation and transplantation. Cell Tissue Bank. 2021;22(2):191–7. doi: 10.1007/s10561-020-09863-y. DOI: https://doi.org/10.1007/s10561-020-09863-y
25. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (2025). Available from: https://dctd.cancer.gov/research/ctep-trials/for-sites/adverse-events (accessed 01.10.2025).
26. WMDA SPEAR Report 2023. SPEAR Annual Reports. Available from: https://share.wmda.info/display/PromotingDonorCare/SPEAR+Annual+Reports (accessed 01.10.2025).