Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Healthy Blood Donors

Exclusion Criteria

• •a) Collection or loss of:
• •* more than a ½ pint (1 cup) of whole blood within the prior 56 days or,
• •* more than 3 L (liter) of whole blood or 1.5 L of red blood cells within the prior 12 months or,
• •* more than 12 L of plasma within the prior 12 months or,
• •* a leukapheresis within the prior six weeks or,
• •* a plateletpheresis within the prior 48 hours or two within the prior 7 days or twenty-four within the last 12 months or,
• •* a plasmapheresis within the prior 48 hours or two within the prior 7 days.
• •Acute or symptomatic chronic lung disease.
• •Active or chronic heart disease, including hypertension controlled by medication.
• •History of hematologic malignancy or chronic hematologic disorder or bleeding disorder.
• •Reactive test indicative of infection with T. pallidum, Human T-lymphotropic virus, HIV, Hepatitis C Virus, or Hepatitis B Virus (except isolated Hepatitis B Core Antibody Reactivity.
• •Presence of psychological traits or physiological or medical conditions that would make subject unlikely to tolerate the procedures.
• •Subjects taking prescription medications other than those deemed allowable by the investigator.
• •Abnormal serum electrolytes or serum calcium levels.
• •Abnormal serum creatinine level.
• •Abnormal liver function results on ALT (alanine amino transferase) test.
• •Abnormal coagulation testing on prothrombin time or partial thromboplastin time.
• •Inadequate antecubital veins for leukapheresis or inability or unwillingness to tolerate leukapheresis.
• •Received a G-CSF injection in the prior 4 months, or received more than twenty-five (25) doses of G-CSF (a dose includes several individual injections administered on one occasion).
• •Known hypersensitivity to G-CSF or any E. coli-derived products.
• •History of autoimmune condition or disorder, unless approved by principal investigator.
• •Immediate family history (parents, grandparents, siblings, children) of hematologic malignancy.
• •Active or history of iritis (anterior uveitis) or episcleritis.
• •History of deep vein thrombosis or pulmonary embolism.
• •Current treatment with lithium.
• •Spleen tip palpable during physical exam.
• •Positive SickleDex test.