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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

Authors

  • M. M. Mueller,

    1. German Red Cross Blood Transfusion Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
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  • H. Bialleck,

    1. German Red Cross Blood Transfusion Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
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  • B. Bomke,

    1. German Red Cross Blood Transfusion Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
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    • Present address: Department of Hemostaseology and Transfusion Medicine, Heinrich-Heine University Medical Center, Duesseldorf, Germany.

  • S. Brauninger,

    1. German Red Cross Blood Transfusion Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
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  • C. Varga,

    1. German Red Cross Blood Transfusion Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
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  • C. Seidl,

    1. German Red Cross Blood Transfusion Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
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  • E. Seifried,

    1. German Red Cross Blood Transfusion Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
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  • T. Tonn,

    1. German Red Cross Blood Transfusion Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
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    • Present address: German Red Cross Blood Service East and Institute for Transfusion Medicine of the Carl Gustav Carus Technical University, Medical Faculty, Dresden, Germany.

  • H. Bonig

    1. German Red Cross Blood Transfusion Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany
    2. Department of Medicine/Hematology, University of Washington, Seattle, WA, USA
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Halvard Bonig, German Red Cross Blood Transfusion Service Baden-Wuerttemberg-Hessen, Sandhofstrasse 1, 60528 Frankfurt, Germany
E-mail: h.boenig@blutspende.de

Abstract

Background and Objectives  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.

Patients and 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.

Conclusion  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.

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