title: Safety and efficacy of healthy volunteer stem cell mobilization with filgrastim G-CSF and mobilized stem cell apheresis: results of a prospective longitudinal 5-year follow-up study.
abstract: OBJECTIVE
  G-CSF-mobilized peripheral blood stem cells have long replaced marrow as the major source for allogeneic transplants. Conclusive evidence questioning the long-term safety of G-CSF for donors has not been provided, but the cumulative number of followed donors remains insufficient to rule out rare adverse events. A long-term active follow-up study of G-CSF-mobilized healthy volunteer donors was therefore performed.
  
  
  METHODS
  Two hundred and three successive donors were evaluated pre-apheresis, subjected to G-CSF-mobilization/apheresis, and actively followed for 5 years by the same physicians and laboratories. Follow-up laboratory work included standard biochemical/haematological tests and T-cell phenotyping.
  
  
  RESULTS
  Donor epidemiology was typical for reported stem cell donor cohorts. Acute adverse effects of G-CSF and apheresis were mild and transient, consistent with the previous reports. Mean circulating CD34(+) cells after nine doses of G-CSF were 124 per μl. Other biochemical/haematological parameters were also altered, consistent with G-CSF treatment. Spleen enlargement was modest. At first follow-up, all clinical and laboratory parameters had normalized. Leucocyte/lymphocyte counts and CD4/CD8 ratios were the same as during premobilization work-up and remained unchanged throughout. A single severe but likely unrelated adverse event, a case of papillary thyroid carcinoma, was reported.
  
  
  CONCLUSIONS
  The studies add an observation time of almost 500 donor years to the growing body of evidence of the long-term safety of G-CSF for allogeneic donor stem cell mobilization.
authors: German Red Cross Blood Transfusion Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany.
authors: M M
authors: MM
authors: Mueller
authors: H
authors: H
authors: Bialleck
authors: B
authors: B
authors: Bomke
authors: S
authors: S
authors: Brauninger
authors: C
authors: C
authors: Varga
authors: C
authors: C
authors: Seidl
authors: E
authors: E
authors: Seifried
authors: T
authors: T
authors: Tonn
authors: H
authors: H
authors: Bonig
mesh_terms: D000328:Adult; D018952:Antigens, CD34 / Q000096:biosynthesis; D001781:Blood Component Removal / Q000379:methods*; D058731:Blood Safety; D015496:CD4-Positive T-Lymphocytes / Q000166:cytology; D018414:CD8-Positive T-Lymphocytes / Q000166:cytology; D005260:Female; D000069585:Filgrastim; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000378:metabolism* / Q000494:pharmacology; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D006801:Humans; D008137:Longitudinal Studies; D018655:Lymphocyte Count; D008297:Male; D010641:Phenotype; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000494:pharmacology; D013234:Stem Cells / Q000166:cytology; D013601:T-Lymphocytes / Q000166:cytology; D014019:Tissue Donors; D014184:Transplantation, Homologous / Q000379:methods
chemical_list: D018952:Antigens, CD34; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim