Ten granulocyte donor were recruited since the last annual report. To date, 79 healthy volunteers were accrued and signed informed consent as active granulocyte donors and donated a total of 242 filgrastim- and dexamethasone-stimulated or filgrastim-alone stimulated granulocyte apheresis components since protocol started. 67 components were collected since last report. Up to 8/29/16 this year , these products were administered to 11 patients with severe neutropenia or neutrophil dysfunction and life-threatening infections; 4 recipients had severe aplastic anemia, 3 had chronic granulomatous disease and 4 were patients transplanted for leukemia or lymphoma . In total, 21 of 39 recipients had fungus or mold (an additional one could not be confirmed, and one of the patients had polymicrobial bacteremia in addition to fungus) and 17 had life-threatening bacterial infections, including two with carbapenem-resistant Klebsiella pneumonia. One gran product was used for research, since patient expired before receipt. As was true this year, a median of 4 granulocyte transfusions (range 1 to 41) were administered per patient course since protocol inception. Since last annual report, 3 of 11 patients did not respond to the granulocyte transfusions (GTX) and died rapidly each having received only 1 GTX: another died despite having received 25 GTX. The remaining 7 improved and were discharged having received 1- 11 GTX. Donors experienced mild to moderate insomnia, nightmares, irritability and jitteriness related to the dexamethasone, and myalgia, arthralgias, fatigue and flushing related to the filgrastim administration. This year 19 donors underwent comprehensive eye exams for cataract detection as an assessment prior to repetitive dexamethasone administration. Donor retention in the program was 78%, with donor loss due to moving away from the Bethesda area or loss of interest. A mean of 7.04 liters were processed per procedure, during which 5.2 x 10e10 granulocytes (range 1.31-9.48 x 10e10) were collected in a volume of 324 mL. Granulocyte collection efficiency was only 42% using the Spectra apheresis device, with WBC differential composed of 84.3% granulocytes, and with a mean hematocrit of 8.3% and a mean red cell content of 27 mL. An oral presentation resulting from data analysis entitled Comparison of the efficacy on granulocyte yield of G-CSF plus dexamethasone versus G-CSF alone mobilization regimens in granulocytapheresis donors over 20 years , Hong H, Yau YY, Cantilena C (Special Issue Abstracts From the American Society for Apheresis 37th Annual Meeting, May 47, 2016 Palm Springs, California (pages 71140) pg 16) Two protocol amendments were approved and are underway. (1) Evaluation of bone mineral density in granulocyte donors and (2) Assessment of renal function in granulocyte donors.
