TY  - JOUR
A1  - Heyn, Jens Michael
A1  - Bräuninger, Susanne Barbara
A1  - Dimova-Dobreva, Miryana
A1  - Mathieson, Nicola
A1  - Koptelova, Natalia V.
A1  - Kolpakova, Anna
A1  - Seidl, Christian
A1  - Reinhardt, Peter
A1  - Tsamadou, Chrysanthi
A1  - Schrezenmeier, Hubert
A1  - Nakov, Roumen
A1  - Seifried, Erhard
A1  - Bönig, Halvard-Björn
T1  - Superior physical and mental health of healthy volunteers before and five years after mobilized stem cell donation
T2  - Journal of translational medicine
N2  - 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
KW  - Healthy stem cell donors
KW  - Filgrastim
KW  - Physical and mental health
KW  - SF-12
Y1  - 2022
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/69509
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-695091
SN  - 1479-5876
N1  - Open Access funding enabled and organized by Projekt DEAL.
N1  - This study is funded by Sandoz biopharmaceuticals/Hexal AG.
VL  - 20
IS  - art. 121
SP  - 1
EP  - 8
PB  - BioMed Central
CY  - London
ER  -