Study population
A total of 119 healthy donors were included in this study. All cases were stratified into 4 different groups, including a control group. The control group consisted of 30 donors. The donors, except those in the control group, received 3 different G-CSFs, i.e. biosimilar filgrastim (Leucostim®) (n=29), original filgrastim (Neupogen®) (n=30), and lenograstim (Granocyte®) (n=30) by subcutaneous administration 24 hours before the BM product was collected. Median age of the donors participating in the study was 13 (1-55) years and 51.3% (61 patients) were female. There was no statistically significant difference between the drug groups and demographic variables. (Table 1)
There was no statistically significant difference between the initial hemogram measurements of the donors across the groups, including the control group. However, in the hemogram measurements obtained immediately before collecting the BM product at 24 hours after G-CSF administration, a statistically significant difference was noted between the groups in WBC-2, PNL-2, and BASO-2 measurements.
The median WBC-2 value of the control group was statistically significantly lower than the other groups, while the median WBC value of the group receiving lenograstim (Granocyte®) was statistically significantly higher than the other groups, and there was no difference in terms of WBC-2 between the healthy donors who received biosimilar filgrastim (Leucostim®) and the original filgrastim (Neupogen®) product. There was no statistically significant difference in median PNL-2 values among the treated (G-CSF) donor groups. In addition, the median BASO-2 value was found to be higher in the control group than the groups that received G-CSF. When the first and second hemogram measurements of the donors receiving G-CSF were evaluated, a statistically significant change was found in all groups (Table 2).
There was no statistically significant difference between the groups in terms of WBC count of the product collected from the bone marrow. However, there was a statistically significant difference between the groups in terms of CD34/UL amount per microliter in the product. When the reason for the difference in CD34/UL was investigated, it was determined that the group receiving lenograstim (Granocyte®) had a statistically significantly higher CD34/UL value compared to the other groups. On the other hand, no statistically significant difference was found in terms of median CD34/UL values between the control group and the groups that received biosimilar filgrastim (Leucostim®) or original filgrastim (Neupogen®) (Table 3).
When the collected bone marrow product was assessed in terms of cell subgroups [CD34, T-cell cytotoxic (CD8/UL), T-cell helper (CD4/UL), B-cell (CD19/UL) and NK cell (CD16/UL)], a statistically significant difference was found only in terms of B cells between the control group and the group receiving original filgrastim (Neupogen®) (p=0.003).