[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]

Abstract

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.

Conclusion: 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.