Evaluation of the Spectra Optia PMN Cell Collection Procedure

The purpose of this study is to compare the procedures for the collection of granulocyte/ polymorphonuclear (PMN) cells on Terumo BCT's Spectra Optia® and COBE® Spectra Apheresis Systems and to establish the non-inferiority of the Spectra Optia Apheresis System with respect to the primary study endpoint, granulocyte/PMN cell collection efficiency.

Inclusion criteria

• Acceptable health status and vital signs per the AABB blood donation guidelines to permit blood donation, including:

• Blood pressure ≥ 90/50 and ≤ 200/120 mmHg,
• Pulse > 40 and < 100 beats/min, and
• Temperature < 99.5ºFahrenheit (F).
• Able to read, understand, and sign an English informed consent form.
• Age ≥ 18 years.
• Weight ≥ 50kg and < 227kg.
• Male or non-pregnant, non-nursing female (a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each mobilization).
• Acceptable screening laboratory test results prior to the first PMN cell mobilization, including:

• WBC count in the range: 3,500-10,800/uL,
• Hematocrit in the range: 38-65%,
• Platelet count in the range: 150,000-400,000/uL,
• Coagulation tests: PT not greater than 1.1 times the upper limit of the local laboratory reference range; PTT not greater than 1.2 times the upper limit of the local laboratory reference range,
• Serum electrolyte concentrations: potassium in the range 3.6-5.1 mmol/L; calcium in the range 8.5-10.3 mg/dL,
• Serum creatinine not greater than 1.5mg/dL, and
• ALT not greater than 1.5 times the upper limit of the local laboratory reference range. *** Up to two (2) of the above screening laboratory test results may fall outside of these ranges, if in the judgment of the principal investigator or designee, they do not constitute a significant risk to the subject. Any excused deviations from the above will be listed and summarized with the final report.***
• Adequate dual peripheral venous access to allow collection of granulocytes (PMN cells) and return of remaining cells, platelets and plasma.
• If male, willing to use a condom during sexual relations with a female partner of child bearing potential until 48 hours following each G-CSF injection.
• If female, willing to use a medically-acceptable contraceptive until 48 hours following each G-CSF injection.

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:

• more than 550mL of whole blood within the prior 56 days, or
• more than 3L of whole blood or 1.5L of red blood cells within the prior 12 months, or
• more than 12L 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.
• 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.