Journal of Translational Medicine (Mar 2022)

Superior physical and mental health of healthy volunteers before and five years after mobilized stem cell donation

  • J. Heyn,
  • S. Bräuninger,
  • M. Dimova-Dobreva,
  • N. Mathieson,
  • N. Koptelova,
  • A. Kolpakova,
  • C. Seidl,
  • P. Reinhardt,
  • C. Tsamadou,
  • H. Schrezenmeier,
  • R. Nakov,
  • E. Seifried,
  • H. Bonig

DOI
https://doi.org/10.1186/s12967-022-03322-w
Journal volume & issue
Vol. 20, no. 1
pp. 1 – 8

Abstract

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Abstract 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

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