A prospective randomized study on the mobilization of CD34+ cells comparing continuous intravenous vs subcutaneous administration of rhG-CSF in normal donors

Abstract

Summary:The efficacy of mobilizing peripheral blood progenitor cells (PBPC) with continuous intravenous (c.i.v.) administration of rhG-CSF was randomly compared to subcutaneous (s.c.) administration, in 15 normal donors in each arm of the study for 6 days. The percentage and absolute numbers of CD34 þ cells in the c.i.v. and s.c. groups increased maximally at day 3 and 5, respectively, when compared with the steady-state (day 0) level. Peak CD34 þ cell levels were achieved on day 3 in the c.i.v. group, with more rapid results than in the s.c. group (49.3/ ll vs 35.9/ll, P ¼ 0.043). Plasma rhG-CSF levels declined progressively during mobilization in each group as the WBC increased. The serum level of rhG-CSF did not correlate with CD34 þ cell counts in the peripheral blood. Toxicity profiles in the c.i.v. and s.c. groups were similar. Each regimen was effective in successfully mobilizing the target CD34 cell number.

Pegylated granulocyte colony-stimulating factor mobilizes CD34+ cells with different stem and progenitor subsets and distinct functional properties in comparison with unconjugated granulocyte colony-stimulating factor

“…53 The authors found that CD34 + cell peak concentrations were reached 2 days earlier following continuous intravenous G-CSF administration compared to daily subcutaneous injections. These findings and the mobilization kinetics observed following the administration of Peg-G-CSF suggest that the timecourse of stimulation (pulsatile versus continuous), rather than a dose-related mechanism, might account for the distinct effects of Peg-G-CSF and G-CSF on stem and progenitor cells.…”

Basal levels of CD34 positive cells in peripheral blood differ between individuals and are stable for 18 months

“…These studies are based on a dual platform protocol as the correlation between WBC and CD34 absolute amounts were an essential aspect of the respective studies. While multiple groups (12–15) have shown variability in basal levels of CD34, the question remains if this variability is reflective of biological differences in individuals or is it a part of the variability in measuring very low levels of cells.…”

Subcutaneous versus intravenous granulocyte colony stimulating factor for the treatment of neutropenia in hospitalized hemato‐oncological patients: Randomized controlled trial

“…Previous studies comparing SC versus IV administration of G-CSF were pharmacokinetic, in vivo or clinical studies on healthy individuals or laboratory animals (Supporting Information Table 2s) [6][7][8][9]15,16] These studies suggest that IV administration results in higher and earlier peak neutrophil counts, but following the peak, levels are higher and maintained for longer with SC administration. The peak after bolus IV administration occurred earlier (12 hrs.)…”

“…IV administration has been used in randomized controlled trials of G-CSF in acute leukemia [4]. In vivo models [6] and studies in healthy people [7][8][9] show that SC administration of G-CSF results in lower peak but more prolonged and stable levels of G-CSF compared with IV administration, with similar or higher peak neutrophil counts. The American Society of Clinical Oncology (ASCO) recommendations state that the preferred route of G-CSF administration is SC, without an explanation or evidence to back this recommendation [10].…”