Jens Michael Heyn, Susanne Barbara Bräuninger, Miryana Dimova-Dobreva, Nicola Mathieson, Natalia V. Koptelova, Anna Kolpakova, Christian Seidl, Peter Reinhardt, Chrysanthi Tsamadou, Hubert Schrezenmeier, Roumen Nakov, Erhard Seifried, Halvard-Björn Bönig
- Background: Safety, tolerability and efficacy of granulocyte colony-stimulating factor (G-CSF) for mobilization of hematopoietic stem and progenitor cells (HSPCs) from healthy donors have been conclusively demonstrated. This explicitly includes, albeit for smaller cohorts and shorter observation periods, biosimilar G-CSFs. HSPC donation is non-remunerated, its sole reward being “warm glow”, hence harm to donors must be avoided with maximal certitude. To ascertain, therefore, long-term physical and mental health effects of HSPC donation, a cohort of G-CSF mobilized donors was followed longitudinally.
Methods: We enrolled 245 healthy volunteers in this bi-centric long-term surveillance study. 244 healthy volunteers began mobilization with twice-daily Sandoz biosimilar filgrastim and 242 underwent apheresis after G-CSF mobilization. Physical and mental health were followed up over a period of 5-years using the validated SF-12 health questionnaire.
Results: Baseline physical and mental health of HSPC donors was markedly better than in a healthy reference population matched for ethnicity, sex and age. Physical, but not mental health was sharply diminished at the time of apheresis, likely due to side effects of biosimilar G-CSF, however had returned to pre-apheresis values by the next follow-up appointment after 6 months. Physical and mental health slightly deteriorated over time with kinetics reflecting the known effects of aging. Hence, superior physical and mental health compared to the general healthy non-donor population was maintained over time.
Conclusions: HSPC donors are of better overall physical and mental health than the average healthy non-donor. Superior well-being is maintained over time, supporting the favorable risk–benefit assessment of volunteer HSPC donation.
Trial registration National Clinical Trial NCT01766934
MetadatenVerfasserangaben: | Jens Michael HeynGND, Susanne Barbara BräuningerGND, Miryana Dimova-Dobreva, Nicola Mathieson, Natalia V. Koptelova, Anna Kolpakova, Christian Seidl, Peter ReinhardtGND, Chrysanthi TsamadouORCiDGND, Hubert SchrezenmeierORCiDGND, Roumen Nakov, Erhard SeifriedORCiDGND, Halvard-Björn BönigORCiDGND |
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URN: | urn:nbn:de:hebis:30:3-695091 |
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DOI: | https://doi.org/10.1186/s12967-022-03322-w |
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ISSN: | 1479-5876 |
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Titel des übergeordneten Werkes (Englisch): | Journal of translational medicine |
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Verlag: | BioMed Central |
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Verlagsort: | London |
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Dokumentart: | Wissenschaftlicher Artikel |
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Sprache: | Englisch |
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Datum der Veröffentlichung (online): | 14.03.2022 |
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Datum der Erstveröffentlichung: | 14.03.2022 |
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Veröffentlichende Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Datum der Freischaltung: | 02.06.2023 |
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Freies Schlagwort / Tag: | Filgrastim; Healthy stem cell donors; Physical and mental health; SF-12 |
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Jahrgang: | 20 |
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Ausgabe / Heft: | art. 121 |
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Aufsatznummer: | 121 |
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Seitenzahl: | 8 |
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Erste Seite: | 1 |
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Letzte Seite: | 8 |
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Bemerkung: | Open Access funding enabled and organized by Projekt DEAL. |
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Bemerkung: | This study is funded by Sandoz biopharmaceuticals/Hexal AG. |
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Institute: | Medizin |
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DDC-Klassifikation: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Lizenz (Deutsch): | Creative Commons - CC BY - Namensnennung 4.0 International |
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