[Randomized clinical study for two types of recombinant human granulocyte colony-stimulating factor mobilizing peripheral blood and bone marrow stem cells in patients receiving allogeneic hematopoietic stem cell transplantation].
OBJECTIVE
To compare mobilization kinetics of CD34 + cells and MNC during mobilization with either recombinant human granulocyte colony-stimulating factor (rHuG-CSF) filgrastim (Huierxue) or topneuter (Teerjin) in allogeneic hematopoietic stem cells transplantation (allo-HSCT) donors.


METHODS
Two different agents of rHuG-CSF, Huierxue (filgrastim) and Teerjin (topneuter), were used for hematopoietic stem cells (HSC) mobilization. The HSCs mobilized by each agent were compared in mobilization efficacy, quality of stem cells, side effects in donors and influence of hematopoietic reconstitution in 52 subjects following allo-HSCT. Fifty-two HLA-matched sibling donors, receiving either (rHuG-CSF) topneuter (treatment group) or filgrastim (control group), were randomized in this study.


RESULTS
The peak values of both groups, occurring at both Day 4, were (38.9 +/- 3.0) x 10(9)/L and (37.8 +/- 2.9) x 10(9)/L respectively (P > 0.05). Both agents had the following effects upon the HSC parameters: (4.8 +/- 0.7) x 10(8)/kg vs (5.1 +/- 0.4) x 10(8)/kg MNC, (1.6 +/- 0.3) x 10(6)/kg vs (1.9 +/- 0.7) x 10(6)/kg) CD34 + in peripheral blood of donors; (3.8 +/- 0.5)/L vs (3.9 +/- 0.7)/L MNC; (1.3 +/- 0.7) x 10(6)/kg vs (1.5 +/- 0.4) x 10(6)/kg CD34 + in bone marrow of donors (both P > 0.05). With regards to the effects upon hematopoietic reconstitution in subjects following allo-HSCT, both had rapid platelet count recovery (14.6 +/- 0.9) vs (15.2 +/-1.6) days (P > 0.05) and neutrophil count recovery (18.1 +/- 0.8) vs (17.0 +/- 1.9) days (P > 0.05). The adverse events were not significantly different in the HSC donors for these two mobilization agents.


CONCLUSIONS
Filgrastim and topneuter demonstrate no statistically significant difference in either HSC mobilization kinetics of peripheral and bone marrow blood or hematopoietic reconstitution. Topneuter can be a reliable agent for donor HSC mobilization and recipient hematopoietic reconstitution following allo-HSCT.
Zhang
Xiao-Hui
XH
Institute of Hematology, Peking University People's Hospital, Beijing 100044, China.
Huang
Xiao-Jun
XJ
Liu
Dai-Hong
DH
Liu
Kai-Yan
KY
Han
Wei
W
Chen
Huan
H
Wang
Feng-Rong
FR
Chen
Yu-Hong
YH
Wang
Jing-Zhi
JZ
Zhao
Ting
T
Wang
Yu
Y
Xu
Lan-Ping
LP
D000293:Adolescent; D000328:Adult; D001854:Bone Marrow Cells / Q000187:drug effects; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006412:Hematopoietic Stem Cells / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D014019:Tissue Donors; D055815:Young Adult
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim