The administration of granulocyte colony-stimulating factor (G-CSF) to increase the white blood cell count in granulocyte donors prior to donation is becoming an increasingly common practice. G-CSF is given subcutaneously to the donor on the day prior to donation, generally 12 to 24 hours before the start of apheresis. It would be advan-tageous to be able to give G-CSF and collect granulocytes on the same day. However, the single most important factor in optimizing granulocyte collection is the donors pre-collec-tion granulocyte count. Therefore, any decrease in count would result in a less cellular component. The purpose of this study is to assess granulocyte counts in healthy subjects during an 8-hour period after a single 5 mg/kg intravenous dose of G-CSF with or without dexamethasone. Sixteen subjects will be studied. Each donor will be studied four separate times. The four mobilization protocols to be studied are G-CSF 5 mg/kg given intravenously, G-CSF 5 mg/kg subcutaneously, G-CSF 5 mg/kg intravenously plus dexamethasone 8 mg orally, and G-CSF 5 mg/kg subcutaneously plus dexamethasone 8 mg orally. The order of the route of administration will be assigned randomly. White blood cell counts, neutrophil counts and donor symptoms will be measured before G-CSF administration and at 1, 2, 4, 6, 8, and 24 hours after administration. The neutrophil counts measured within the first 8 hours after G-CSF will be compared with counts measured 24 hours after G-CSF. This study has just begun and no data are available.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL002099-01
Application #
6227877
Study Section
Special Emphasis Panel (DTM)
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code
Jin, Ping; Wang, Ena; Ren, Jiaqiang et al. (2008) Differentiation of two types of mobilized peripheral blood stem cells by microRNA and cDNA expression analysis. J Transl Med 6:39
Ren, Jiaqiang; Jin, Ping; Wang, Ena et al. (2007) Pancreatic islet cell therapy for type I diabetes: understanding the effects of glucose stimulation on islets in order to produce better islets for transplantation. J Transl Med 5:1
Stroncek, David F; Jin, Ping; Wang, Ena et al. (2007) Potency analysis of cellular therapies: the emerging role of molecular assays. J Transl Med 5:24
Stroncek, David; Slezak, Stefanie; Khuu, Hanh et al. (2005) Proteomic signature of myeloproliferation and neutrophilia: analysis of serum and plasma from healthy subjects given granulocyte colony-stimulating factor. Exp Hematol 33:1109-17
Stroncek, David; Dittmar, Kristin; Shawker, Thomas et al. (2004) Transient spleen enlargement in peripheral blood progenitor cell donors given G-CSF. J Transl Med 2:25
Stroncek, David; Shawker, Thomas; Follmann, Dean et al. (2003) G-CSF-induced spleen size changes in peripheral blood progenitor cell donors. Transfusion 43:609-13
Stroncek, David F; Matthews, Cynthia L; Follmann, Dean et al. (2002) Kinetics of G-CSF-induced granulocyte mobilization in healthy subjects: effects of route of administration and addition of dexamethasone. Transfusion 42:597-602
Stroncek, D F; Confer, D L; Leitman, S F (2000) Peripheral blood progenitor cells for HPC transplants involving unrelated donors. Transfusion 40:731-41