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Collection of two consecutive neutrophil concentrates for transfusion from donors mobilized with glycosylated granulocyte‐CSF plus dexamethasone

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BACKGROUND: The objective of this study was to establish a mobilization and apheresis regimen for collection of two consecutive polymorphonuclear neutrophil (PMN) concentrates from the same donor.STUDY DESIGN AND METHODS: In this prospective study, 111 healthy unrelated volunteers underwent either one (Group 1, n = 57) or two consecutive granulocyte apheresis procedure (Group 2, n = 54) using the a cell separator (Spectra). Both Group 1 and 2 donors were initially mobilized with glycosylated G‐CSF 6.0 µg per kg (range, 5.2‐7.0 µg/kg) subcutaneously plus oral dexa‐methasone (DXM, 8 mg) and underwent granulocyte apheresis (GA‐1) 16 hours (range, 13‐18 hr) after initial G‐CSF+DXM. Group 2 donors were remobilized with a second DXM dose of 8 mg (n = 13), 4 mg (n = 15), 1.5 mg (n = 13), or none (n = 13), and a second apheresis (GA‐2) was run 40 hours (range, 37‐42 hr) after G‐CSF+DXM administration and 12 hours after remobilization with DXM alone.RESULTS: Based on equivalent median preapheresis WBC and PMN counts of around 35 × 109 WBCs per L and 33 × 109 PMNs per L after initial mobilization the GA‐1 yields were 85 × 109 PMNs per U (range, 34‐150) in Group 1 and 75 × 109 PMNs per U (range, 35‐135) in Group 2 (p = 0.14, NS). In Group 2, median preapheresis values of 19.6 × 109 WBCs per L (range, 9.5‐37.0) and 16.6 × 109 PMNs per L (range, 8.8‐34.8) were measured after remobilization and GA‐2 yields of 49 × 109 WBCs per U (range, 26‐113) and 42 × 109 PMNs per U (range, 21‐95) were obtained. Borderline statistical differences in the GA‐2 yields were observed from the remobilized donors: 8 mg: 36 × 109 PMNs per U (range, 23‐60); 4 mg: 47 × 109 PMNs per U (range, 21‐56) (p ≤ 0.04); 1.5 mg: 45 × 109 PMNs per U (range, 23‐79); placebo: 36 × 109 PMNs per U (range, 26‐95) (p ≤ 0.04).CONCLUSION: Two consecutive neutrophil concentrates for transfusion can be obtained after single stimulation with Lenograstim+DXM. A second application of DXM alone is necessary, but of limited value.
Title: Collection of two consecutive neutrophil concentrates for transfusion from donors mobilized with glycosylated granulocyte‐CSF plus dexamethasone
Description:
BACKGROUND: The objective of this study was to establish a mobilization and apheresis regimen for collection of two consecutive polymorphonuclear neutrophil (PMN) concentrates from the same donor.
STUDY DESIGN AND METHODS: In this prospective study, 111 healthy unrelated volunteers underwent either one (Group 1, n = 57) or two consecutive granulocyte apheresis procedure (Group 2, n = 54) using the a cell separator (Spectra).
Both Group 1 and 2 donors were initially mobilized with glycosylated G‐CSF 6.
0 µg per kg (range, 5.
2‐7.
0 µg/kg) subcutaneously plus oral dexa‐methasone (DXM, 8 mg) and underwent granulocyte apheresis (GA‐1) 16 hours (range, 13‐18 hr) after initial G‐CSF+DXM.
Group 2 donors were remobilized with a second DXM dose of 8 mg (n = 13), 4 mg (n = 15), 1.
5 mg (n = 13), or none (n = 13), and a second apheresis (GA‐2) was run 40 hours (range, 37‐42 hr) after G‐CSF+DXM administration and 12 hours after remobilization with DXM alone.
RESULTS: Based on equivalent median preapheresis WBC and PMN counts of around 35 × 109 WBCs per L and 33 × 109 PMNs per L after initial mobilization the GA‐1 yields were 85 × 109 PMNs per U (range, 34‐150) in Group 1 and 75 × 109 PMNs per U (range, 35‐135) in Group 2 (p = 0.
14, NS).
In Group 2, median preapheresis values of 19.
6 × 109 WBCs per L (range, 9.
5‐37.
0) and 16.
6 × 109 PMNs per L (range, 8.
8‐34.
8) were measured after remobilization and GA‐2 yields of 49 × 109 WBCs per U (range, 26‐113) and 42 × 109 PMNs per U (range, 21‐95) were obtained.
Borderline statistical differences in the GA‐2 yields were observed from the remobilized donors: 8 mg: 36 × 109 PMNs per U (range, 23‐60); 4 mg: 47 × 109 PMNs per U (range, 21‐56) (p ≤ 0.
04); 1.
5 mg: 45 × 109 PMNs per U (range, 23‐79); placebo: 36 × 109 PMNs per U (range, 26‐95) (p ≤ 0.
04).
CONCLUSION: Two consecutive neutrophil concentrates for transfusion can be obtained after single stimulation with Lenograstim+DXM.
A second application of DXM alone is necessary, but of limited value.

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