Mobilization of PBSC for allogeneic transplantation by the use of the G-CSF biosimilar XM02 in healthy donors.

Abstract:

:The human recombinant G-CSF filgrastim has been widely used for the mobilization of CD34(+) stem cells of healthy donors (HD). In 2008, the G-CSF biosimilar XM02 (Ratiograstim, Tevagrastim and Biograstim) was approved by the European Medicines Agency (EMA) for the mobilization of PBSC. However, there is limited experience in the application of biosimilar G-CSF for the mobilization of PBSC especially in HD. Therefore, we investigated in two cohorts (n=22), the efficacy and safety of PBSC mobilization by either biosimilar G-CSF or reference G-CSF. We observed a similar yield of CD34(+) stem cells as well as CD3(+) T-cells and nucleated cells in both groups and a safe engraftment in all patients with similar reconstitution of hematopoiesis in all hosts. In summary, we found a comparable efficacy and safety of biosimilar G-CSF when compared with reference G-CSF.

journal_name

Bone Marrow Transplant

authors

Schmitt M,Xu X,Hilgendorf I,Schneider C,Borchert K,Gläser D,Freund M,Schmitt A

doi

10.1038/bmt.2012.270

subject

Has Abstract

pub_date

2013-07-01 00:00:00

pages

922-5

issue

7

eissn

0268-3369

issn

1476-5365

pii

bmt2012270

journal_volume

48

pub_type

临床试验,杂志文章
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