Mobilized leukopaks are collected under an IRB-approved protocol from normal healthy individuals and qualified in accordance with current regulations and requirements for donors of transfusable blood components. This includes screening with the Uniform Donor History Questionnaire that was developed by the AABB and accepted by the Food and Drug Administration for screening of donors of transfusable blood components.

All donors are prescreened for evidence of transfusion-transmissible infectious diseases with the standard panel of tests used to screen blood products for transfusion acceptability, which include HBV, HCV, HIV, HTLV, WNV, Trypanosoma cruzi, and Syphilis. Testing for exposure to Babesia microti is performed for donors in selected geographic regions in accordance with FDA recommendations.

Mobilized leukopaks are collected in our FDA-registered collection centers by leukapheresis using the Spectra Optia® Apheresis System. Depending on selected dosing option, HemaCare’s mobilized leukopaks are prepared using either G-CSF (Neupogen®), Mozobil® (plerixafor), or a combination of both.

Dosing Regimen Options

The mobilization and collection schedules for the available regimens are as follows:

G-CSF

Three G-CSF mobilization options are available:

• 5-10µg/kilogram body weight X 4 days, single collection on day 5
• 5-10µg/kilogram body weight X 5 days, single collection on day 6
• 5-10 µg/kilogram body weight X 5 days, 2 collections, one on day 5, and one on day 6

Mozobil®

Three Mozobil® mobilization options are available:

• 0.24mg/kg/day up to 24mg/day X 1 day, single collection on day 1
• 0.24mg/kg/day up to 24mg/day X 1 day, 2 collections, one on day 1, and one on day 2
• 0.24mg/kg/day up to 24mg/day X 2 days, 2 collections, one on day 1, and one on day 2

G-CSF + Mozobil®

Two combination mobilization options (plerixafor + G-CSF) are available:

• 5-10µg/kilogram body weight X 5 days, 0.24mg/kg/day up to 24mg/day X 1 day (day 5), single collection on day 6
• 5-10µg/kilogram body weight X 5 days, 0.24mg/kg/day up to 24mg/day X 2 days (days 4 and 5), 2 collections, one on day 1, and one on day 2