title: Automatic interface-controlled apheresis collection of stem/progenitor cells: results from an autologous donor validation trial of a novel stem cell apheresis device.
abstract: BACKGROUND
  Cryopreserved hematopoietic progenitor cells collected by apheresis from granulocyte-colony-stimulating factor with or without chemotherapy-mobilized patients have become the preferred type of autograft to support treatment of diseases amenable to high-dose chemotherapy. A novel apheresis system, the Spectra Optia v.5.0 (CaridianBCT), was constructed to meet certain shortcomings of manual apheresis systems such as the COBE Spectra MNC (CaridianBCT), including the need for continuous optical or manual monitoring and readjustment of buffy coat position and sensitivity to inconsistent blood flow. By use of optical sensors, which provide real-time automatic interface (buffy coat) and collection line control, the Spectra Optia promises to automatically guide apheresis procedures, potentially freeing up operator time and reducing variability in collection efficiency (CE2).
  
  
  METHODS
  In a two-center clinical trial, 35 autologous stem cell donors were subjected to apheresis with the Spectra Optia to validate feasibility and effectiveness of apheresis procedures. Results were compared to data from 80 autologous apheresis procedures with the COBE Spectra MNC.
  
  
  RESULTS
  Usability and function of the automatic interface management were excellent. CD34+ cell quality, assessed by viability staining, colony-forming unit-culture frequency, and engraftment kinetics, was equally good with both systems. CE2 of the Spectra Optia, calculated as CD34+ contents in the product divided by the number of CD34+ cells presented to the collection port, exceeded that of the COBE Spectra MNC. Spectra Optia product volumes were significantly smaller. Very high white blood cell and platelet counts modestly reduced CE2 with the Spectra Optia.
  
  
  CONCLUSIONS
  The Spectra Optia is a novel automatic apheresis system supporting autologous stem cell collection with at least equal efficiency and superior user-friendliness compared to the COBE Spectra MNC.
authors.affiliation: German Red Cross Blood Service Baden-Württemberg-Hessen and Institute of Clinical Transfusion Medicine and Immunogenetics, University of Ulm, Ulm, Germany. h.boenig@blutspende.de
authors.forename: Peter
authors.initials: P
authors.lastname: Reinhardt
authors.forename: Susanne
authors.initials: S
authors.lastname: Brauninger
authors.forename: Heike
authors.initials: H
authors.lastname: Bialleck
authors.forename: Kristin
authors.initials: K
authors.lastname: Thorausch
authors.forename: Richard
authors.initials: R
authors.lastname: Smith
authors.forename: Hubert
authors.initials: H
authors.lastname: Schrezenmeier
authors.forename: Erhard
authors.initials: E
authors.lastname: Seifried
authors.forename: Markus
authors.initials: M
authors.lastname: Wiesneth
authors.forename: Halvard
authors.initials: H
authors.lastname: Bonig
mesh_terms: D000328:Adult; D000368:Aged; D001781:Blood Component Removal / Q000295:instrumentation* / Q000379:methods; D005260:Female; D006412:Hematopoietic Stem Cells / Q000166:cytology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult