Twenty-nine granulocyte donors were recruited since the last annual report. To date, 111 healthy volunteers were accrued and signed informed consent as active granulocyte donors and donated a total of 330 filgrastim- and dexamethasone-stimulated or filgrastim-alone stimulated granulocyte apheresis components since protocol started. 58 components were collected since last report. Up to 8/31/18 this year, these products were administered to 7 patients with severe neutropenia or neutrophil dysfunction and life-threatening infections; 3 had chronic granulomatous disease and 3 were patients transplanted for SAA and 1 had NSCLC. This past year, 4 recipients had fungus or mold, 3 had life-threatening bacterial infections, including one with Carbapenem-resistant Klebsiella pneumonia. A median of 4 granulocyte transfusions (range 1 to 41) were administered per patient course since protocol inception, as has been true in prior years. Since last annual report, 4 of the 7 patients did not respond to the granulocyte transfusions and died having received only 2 to 9 granulocytes transfusions each. Two patients improved, one of whom has been discharged and one course was discontinued in another patient after 31 granulocyte transfusions for lack of response. None of the 7 patients discontinued granulocyte courses due reactions or alloimmunization, though donors are carefully ABO- or HLA-matched, and when needed products undergo rbc sedimentation. Anticipated side effects of dexamethasone and/or filgrastim occurred in 64% of donors who reported one or more of the following: mild to moderate insomnia, nightmares, irritability and jitteriness, headache, bone or joint pain, fatigue or flushing. Severe symptoms were reported in <1% of donors but persisted for 48 hours in approximately 1/3rd of donors. 21 donors underwent comprehensive eye exams for cataract detection as an assessment prior to repetitive dexamethasone administration. Donor retention in the program was 56%, with donor loss due to moving away from the Bethesda area or loss of interest. A mean of 5.95 liters were processed per procedure, during which 5.9 x 1010 granulocytes (range 0.4-18.8 x 1010) were collected in a volume of 304 mL. Granulocyte collection efficiency was 44.2% using the Spectra Optia apheresis device, with WBC differential composed of 89% granulocytes, and with a mean hematocrit of 6.9% and a mean red cell content of 21 mL. Two protocol amendments were approved and are underway. (1) 69 subjects consented to Evaluation of bone mineral density in granulocyte donors and (2) 100 subjects consented to Assessment of renal function in granulocyte donors. Preliminary data analysis shows that granulocyte donor bone mineral density was what would be expected for normal age and body size, that is, not diminished by repeated dexamethasone doses given before donations. Renal function assessment is underway, but thus far limited by low numbers of control subjects for comparison. A manuscript was accepted for publication in Transfusion journal entitled: The effect of repeated stimulated granulocyte donations on hematopoietic indices in donors: a 24 year donor center experience.
