Harvesting peripheral blood progenitor cells from healthy donors with a short course of recombinant human granulocyte‐colony‐stimulating factor

Abstract

A short-course administration of non-glycosylated granulocyte-colony-stimulating factor (G-CSF) was investigated in 68 healthy donors (HDs) in order to collect > or = 4 x 10(6) CD34+ cells per kilogram of recipient's body weight. G-CSF was given at 10 microg/kg per day administered in two divided doses for 3 days. Leukapheresis was scheduled on day 4, 12 h after the last dose of G-CSF. A median of 35.6 circulating CD34+ cells microL(-1) (range, 3.1-185) was found on the day of leukapheresis. This allowed a median collection of CD34+ cells of 4.2 x 10(6) per kilogram of recipient's weight (range, 1.0-17.4). One single procedure was sufficient to reach the target level of CD34+ cells in 36 (53%) of 68 donors; significant correlations were found between the number of CD34+ cells collected on day 4 and the patient's sex, body-weight and volume of blood processed. A retrospective analysis was made with a historical group of HDs collected on day 5. The day 5 schedule allowed a more consistent achievement of the target cell dose with one leukapheresis (P = 0.005) and resulted in the initial collection of a significantly larger number of CD34+ cells (P = 0.006).

Short and long-term safety of lenograstim administration in healthy peripheral haematopoietic progenitor cell donors: a single centre experience

“…The most frequently described events are mild to moderate in nature and include bone pain, headache, nausea, insomnia, fever, fatigue and reversible changes in laboratory parameters such as increased levels of lactate dehydrogenase and alkaline phosphatase, in addition to thrombocytopenia. [7][8][9] Despite this, isolated cases of severe clinical involvement such as substantial increases in spleen size and, in some cases, a rupture of the organ have been reported. [32][33][34][35][36][37][38][39][40] In this study, the short-term clinical adverse side effects were similar to those described in earlier studies.…”

“…LENO was given s.c. at a total median dose of 10 mg/kg (range [5][6][7][8][9][10][11][12][13][14][15] in two refracted doses every 12 h for 4-7 days, according to the different schedules reported by the literature. [26][27][28] All injections were given at the same time in the morning and in the evening after blood sampling.…”

“…2,3 Avoiding general anaesthesia, surgery (marrow harvesting) and autologous or allogeneic blood transfusions in donors have the potential of making the donation safer, less traumatic and more effective in collecting HPC-A. 4 Although the short-term toxicities of rhG-CSF in donors are well known, [5][6][7][8][9] data on the long-term impact of rhG-CSF in normal donors are scarce, and only a few series involving small numbers of donors have addressed these issues. [10][11][12][13] More widespread use of allogeneic HPC-A may be limited because of the potential risks of the long-term effects of rhG-CSF, [14][15][16][17][18][19][20][21][22] although there are no data in this regard in healthy donors (HDs).…”

Granulocyte-colony stimulating factor administration to healthy individuals and persons with chronic neutropenia or cancer: an overview of safety considerations from the Research on Adverse Drug Events and Reports project

“…13 More recently, researchers in Italy reported bone pain in 52% of healthy donors who received 20 mg/kg/ day for 3 days. 14 The same Italian group further reported bone pain among 62% of healthy donors who received filgrastim in a retrospective study of healthy PBSC donors. 15 An analysis of adverse events among 94 healthy PBSC donors who received G-CSF in Japan reported bone pain in 71% of donors.…”

G-CSF-primed BM for allogeneic SCT: revisited

“…42 However, GPB stem cell harvesting contains a risk of poor progenitor cell mobilization (collection of o 2 × 10 6 /kg CD34+ cells), whereas other adverse events are similar in both options. [43][44][45][46][47][48][49][50][51][52][53][54][55] It is now generally accepted that G-CSF mobilization is a critical process, as it promotes cell cycling of multipotent hematopoietic progenitor cells and increases their numbers in the grafts. Furthermore, it alters the proportion of relevant cell populations and their activation state in the BM and the PB, inducing functional modulations in donor hematopoiesis and immune system.…”