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Cell Procurement

Short and long-term safety of lenograstim administration in healthy peripheral haematopoietic progenitor cell donors: a single centre experience

Bone Marrow Transplantation volume 44, pages 163–168 (2009)Cite this article

Abstract

Healthy donors (HDs) who were mobilized using lenograstim (LENO) and who were undergoing peripheral haematopoietic progenitor cell collection with apheresis (HPC-A) were enrolled in a surveillance protocol. In all, 184 HDs have been assessed with a median follow-up of 62 months (range 2–155). HDs received LENO at a median dose of 10 μg/kg (range 5–15). Bone pain was reported as the most frequent short-term adverse event (71.2%). Other commonly observed short-term symptoms included fatigue (19.0%), fever (5.4%), headache (27.7%), nausea (12.0%) and insomnia (22.3%). Spleen size increased in 4.3% of the donors. No vascular disorders or cardiac disease occurred. Long-term follow-up included monitoring of adverse events, neoplastic disease or other pathologies. Transit ischaemic attack occurred in one donor (39 months post-donation). One autoimmune event was reported at 28 months post-recombinant human granulocyte (rhG)-CSF (ankylosing spondylitis); one donor with a history of chronic obstructive pulmonary disease developed secondary polyglobulia (50 months post-rhG-CSF). One donor was diagnosed with lung cancer at 19 months post-donation. No haematological disease was observed. In conclusion, the short-term safety appears to be verified, whereas, although the study identified no increased risks of malignancy among HDs who received rhG-CSF, long-term safety requires more complete data sets, especially a longer follow-up and a larger number of HDs.

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Authors and Affiliations

  1. UO Ematologia con Trapianto, Azienda Ospedaliera ‘Bianchi-Melacrino-Morelli’, Reggio Calabria, Italy

    M Martino, G Console, A Dattola, I Callea, G Messina, T Moscato, E Massara, G Irrera, R Fedele & P Iacopino

  2. UO Medicina Trasfusionale, Azienda Ospedaliera ‘Bianchi-Melacrino-Morelli’, Reggio Calabria, Italy

    A Gervasi & G Bresolin

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Correspondence to M Martino.

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Martino, M., Console, G., Dattola, A. et al. Short and long-term safety of lenograstim administration in healthy peripheral haematopoietic progenitor cell donors: a single centre experience. Bone Marrow Transplant 44, 163–168 (2009). https://doi.org/10.1038/bmt.2008.440

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