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).