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

Bone Marrow Transplant. 2013 Jul;48(7):922-5. doi: 10.1038/bmt.2012.270. Epub 2013 Jan 14.

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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antigens, CD34 / metabolism
  • Cohort Studies
  • Female
  • Filgrastim
  • Granulocyte Colony-Stimulating Factor / administration & dosage*
  • Granulocyte Colony-Stimulating Factor / adverse effects
  • Hematopoietic Stem Cell Mobilization / methods*
  • Hematopoietic Stem Cells / cytology
  • Hematopoietic Stem Cells / metabolism
  • Humans
  • Leukemia / therapy*
  • Lymphoma, Non-Hodgkin / therapy*
  • Male
  • Middle Aged
  • Peripheral Blood Stem Cell Transplantation*
  • Pilot Projects
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Unrelated Donors*

Substances

  • Antigens, CD34
  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Filgrastim