Administration of recombinant human granulocyte colony-stimulating factor to normal donors: results of the Spanish National Donor Registry

Abstract

A Spanish National PBPC Donor Registry has recently been established for short- and long-term safety data collection in normal donors receiving rhG-CSF. To date, 466 donors have been included in the Registry. Median (range) dose and duration of rhG-CSF administration was 10 μg/kg/day (4–20) and 5 days (4–8), respectively. Donors underwent a median of two aphereses (range, 1–5). Adverse effects consisted mainly of bone pain (90.2%), headache (16.9%) and fever (6.1%), but no donor discontinued rhG-CSF prematurely due to toxicity. Side-effects were more frequent in donors receiving >10 μg/kg/day than in those with lower doses (82.8% vs 61.8%; P = 0.004). A significant decrease between baseline and post-apheresis platelet counts was the most important analytical finding (229 × 10⁹/l vs 140 × 10⁹/l; P < 0.0001), with a progressive reduction in platelet count with each apheresis procedure. one donor developed pneumothorax that required hospitalization due to central venous line placement. the mean cd34⁺ cell dose collected was 6.9 × 10⁶/kg (range, 1.3–36), with only 14 donors (2.9%) not achieving a minimum target of CD34⁺ cells of 2 × 10⁶/kg. No definitive information about potential long-term side effects is yet available. However, we hope this National Registry will serve as a useful basis for better monitoring of the efficiency and side-effects of cytokine administration in healthy people.