Evaluation of the Spectra Optia PMN Cell Collection Procedure

Exclusion Criteria

• •Positive screening for any of the following: HIV, HBV (except isolated HB core Ab reactivity), HCV, HTLV, Syphilis or West Nile Virus.
• •Currently pregnant or breast-feeding.
• •Collection or loss of specific volumes of whole blood or blood components during specified timeframes:
• •1. more than 550mL of whole blood within the prior 56 days, or
• •2. more than 3L of whole blood or 1.5L of red blood cells within the prior 12 months, or
• •3. more than 12L of plasma within the prior 12 months, or
• •4. a leukapheresis within the prior six weeks, or
• •5. a plateletpheresis within the prior 48 hours or two within the prior 7 days or twenty-four within the last 12 months, or
• •6. a plasmapheresis within the prior 48 hours or two within the prior 7 days.
• •History of congestive heart failure.
• •History of uncontrolled hypertension (SBP/DBP \>200/120 mmHg).
• •History or suspicion of active, peptic ulcer disease.
• •History of diabetes mellitus.
• •History of hematologic malignancy or chronic hematologic disorder.
• •Family history (parents, siblings, children) of hematologic malignancy.
• •History of deep vein thrombosis or venous thromboembolism, or bleeding disorder.
• •History of sickle cell disease or a positive SickleDex screen.
• •History of iritis or episcleritis.
• •History of autoimmune condition or disorder, unless approved by principal investigator.
• •Presence of psychological traits, or physiological or medical conditions that, in the opinion of the investigator, would make the subject unlikely to tolerate the procedures or complete the study.
• •History of use/anticipated need for lithium.
• •Received a G-CSF injection in the prior 4 months.
• •Known hypersensitivity to ethylene oxide.
• •Known hypersensitivity to G-CSF or hypersensitivity to any E. coli-derived products.
• •Known hypersensitivity to HES or corn.
• •Concurrent participation in another clinical trial or participation in a clinical trial within the past 30 days.
• •Subject is being treated with calcium channel blockers and/or antiepileptic medications. Note: This applies only to Subjects at Bonfils Blood Center whose collected product will undergo neutrophil function testing.