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

Inclusion criteria

• Acceptable health history to allow blood product collection
• Weight >50<125 Kg (kilogram).
• Male or non-pregnant, non-nursing female.
• General good health, as determined by questionnaire.
• Normal prescreening complete blood count.
• Platelet count>150 x 10^3/uL (microliter) at initial screening and >120 x 10^3/uL immediately prior to leukapheresis.
• Adequate peripheral venous access to allow collection of product.
• Able to read, understand, and sign the informed consent form. Additional Inclusion Criteria for Mobilized Subjects
• If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection.
• If female and of childbearing potential, be willing to use a medically acceptable contraceptive until 48 hours following the last G-CSF injection.

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.
• If female, pregnant or lactating. Additional Exclusion Criteria for Mobilized Subjects
• 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.