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
MetadatenAuthor: | 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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Parent Title (English): | Journal of translational medicine |
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Publisher: | BioMed Central |
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Place of publication: | London |
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Document Type: | Article |
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Language: | English |
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Date of Publication (online): | 2022/03/14 |
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Date of first Publication: | 2022/03/14 |
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Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
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Release Date: | 2023/06/02 |
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Tag: | Filgrastim; Healthy stem cell donors; Physical and mental health; SF-12 |
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Volume: | 20 |
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Issue: | art. 121 |
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Article Number: | 121 |
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Page Number: | 8 |
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First Page: | 1 |
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Last Page: | 8 |
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Note: | Open Access funding enabled and organized by Projekt DEAL. |
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Note: | This study is funded by Sandoz biopharmaceuticals/Hexal AG. |
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Institutes: | Medizin |
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Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
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Sammlungen: | Universitätspublikationen |
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Licence (German): | Creative Commons - CC BY - Namensnennung 4.0 International |
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