An Evaluation of the Spectra Optia CMNC Collection Procedure

Inclusion Criteria

• •1. ≥ 18 and ≤ 50 years of age
• •2. Healthy blood donor criteria as defined by the American Associate of Blood Banks (AABB)
• •a) Note: Subjects who are deferred from volunteer donations because of travel restrictions, piercings or tattoos may participate in the study
• •3. Adequate dual peripheral venous access
• •4. Acceptable prescreening laboratory results prior to MNC mobilization as specified below:
• •a) WBC 3,500 - 10,800/µL
• •b) Hematocrit 38% - 56%
• •c) Platelets 150,000 - 400,000/µL
• •d) Coagulation tests:
• •i. PT 9.0 - 13.0 seconds
• •ii. PTT 23.4 - 41.8 seconds
• •e) Serum electrolytes:
• •i. Potassium 3.6 - 5.1 mmol/L
• •ii. Serum Calcium 8.5 mg/dL - 10.3 mg/dL
• •f) Renal function: Serum creatinine ≤ 1.5 mg/dL
• •NOTE: up to two laboratory results may fall out of the ranges listed above if, in the judgment of the investigator, they do not constitute a significant risk to the subject.
• •5. Liver function: alanine aminotransferase (ALT) \< 1.5 times the upper limit of normal
• •6. Willing to avoid pregnancy until at least 48 hours following last G-CSF injection
• •1. If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection
• •2. If female and of childbearing potential, be willing to use a medically acceptable contraceptive until 48 hours following the last G-CSF injection
• •7. Given written informed consent