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

A Spanish National PBPC Donor Registry has recently been established for sh ort- and long-term safety data collection in normal donors receiving rhG-CS F. To date, 466 donors have been included in the Registry. Median (range) d ose and duration of rhG-CSF administration was 10 mu g/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 mu g/kg/ day than in those with lower doses (82.8% vs 61.8%; P = 0.004). A significa nt decrease between baseline and post-apheresis platelet counts was the mos t important analytical finding (229 x 10(9)/l vs 140 x 10(9)/l; P < 0.0001) , with a progressive reduction in platelet count with each apheresis proced ure. cone donor developed pneumothorax that required hospitalization due to central venous line placement. The mean CD34(+) cell dose collected was 6. 9 x 10(6)/kg(range, 1.3-36), with only 14 donors (2.9%) not achieving a min imum target of CD34(+) cells of 2 x 10(6)/kg. No definitive information abo ut potential long-term side effects is yet available. However, we hope this National Registry will serve as a useful basis for better monitoring of th e efficiency and side-effects of cytokine administration in healthy people.