{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T07:11:21Z","timestamp":1782371481562,"version":"3.54.5"},"reference-count":40,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,7,9]],"date-time":"2025-07-09T00:00:00Z","timestamp":1752019200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100014756","name":"Hexal AG","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100014756","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The application of granulocyte colony\u2010stimulating factors (G\u2010CSF) for mobilizing hematopoietic stem and progenitor cells in healthy donors is considered safe. However, only limited safety information is available about long\u2010term adverse events (AEs) in this setting. To determine the long\u2010term effect of health consequences to stem cell donors, 244\u2009G\u2010CSF\u2010mobilized donors were tracked prospectively for 10\u2009years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>A total of 244 adult healthy unrelated stem cell donors who received at least one dose of Sandoz biosimilar filgrastim were enrolled in this prospective long\u2010term surveillance study. Safety, mental health, and physical health were followed up over a period of 10\u2009years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Ninety\u2010five percent of the donors experience at least one AE during the stem mobilization period; beyond this period, the onset of the first AE was 3.86 [3.45\u20134.27] years in females and 4.02 [3.68\u20134.35] years in males. The risk of reporting an AE was significantly lower in the youngest tertile of donors, when compared to the oldest (<jats:italic>p<\/jats:italic>\u2009=\u20090.026). Females were more likely to report AEs than males (0.40 vs. 0.21 AEs\/year, rate ratio: 1.87 [CI: 1.32\u20132.64]; &lt;0.001). No clinically relevant permanent changes occurred up to 10\u2009years from mobilization in physical or mental health.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>No new or excessive AEs were identified during a 10\u2010year follow\u2010up of mobilized stem cell donors and therefore reassure about the overall safety of stem cell mobilization with G\u2010CSF in healthy volunteers.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.18317","type":"journal-article","created":{"date-parts":[[2025,7,10]],"date-time":"2025-07-10T05:39:59Z","timestamp":1752125999000},"page":"1418-1426","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Healthy volunteer stem cell donors followed up 10\u2009years after stimulation with biosimilar filgrastim"],"prefix":"10.1111","volume":"65","author":[{"given":"Jens","family":"Heyn","sequence":"first","affiliation":[{"name":"Hexal AG (a Sandoz Company)  Holzkirchen 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