title: Fully automated, clinical-grade bone marrow processing: a single-centre experience.
abstract: BACKGROUND
  Clinical grade processing of harvested bone marrow is required in various clinical situations, particularly in the management of ABO mismatching in allogeneic haematopoietic stem cell transplantation (HSCT) and in regenerative medicine.
  
  
  METHODS
  We report a single-centre experience using a fully automated, clinical grade, closed system (Sepax, Biosafe, Switzerland). From 2003 to 2015, 125 procedures were performed in our laboratory, including buffy-coat production for HSCT (n=58), regenerative medicine in an orthopaedic setting (n=54) and density-gradient separation in a trial for treatment of critical limb ischaemia (n=13).
  
  
  RESULTS
  Buffy coat separation resulted in a median volume reduction of 85% (range, 75-87%), providing satisfactory red blood cell depletion (69%, range 30-88%) and a median recovery of CD34 cells of 96% (range, 81-134%) in the setting of allogeneic HSCT. Significantly greater volume reduction (90%; range, 90-92%) and red blood cell depletion (88%; range, 80-93%) were achieved by the new SmartRedux software released for Sepax2, validated in the last eight allogeneic HSCT. The density gradient separation programme resulted in complete red blood cell depletion associated with high CD34 recovery (69%; range, 36-124%). No reactions related to the quality of the product were reported. Time to engraftment following allogeneic HSCT was in the normal range. No cases of microbiological contamination related to the manipulation were reported.
  
  
  CONCLUSIONS
  Clinical grade, automated bone marrow manipulation with Sepax was shown to be effective, giving operator-independent results and could be used for a broad range of clinical applications.
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Benedetta
authors.initials: B
authors.lastname: Mazzanti
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Serena
authors.initials: S
authors.lastname: Urbani
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Dal Pozzo
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Bufano
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Lara
authors.initials: L
authors.lastname: Ballerini
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Gelli
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Sodi
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Donnini
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Gioia
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Guidi
authors.affiliation: Biosafe, Eysin, Switzerland.
authors.forename: Julien
authors.initials: J
authors.lastname: Camisani
authors.affiliation: Cell Therapy and Transfusion Medicine Unit, Cord Blood Bank, Careggi University Hospital, Florence, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Saccardi
mesh_terms: D001854:Bone Marrow Cells / Q000166:cytology; D002469:Cell Separation / Q000295:instrumentation / Q000379:methods*; D005121:Extremities / Q000098:blood supply; D019337:Hematologic Neoplasms / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods; D006412:Hematopoietic Stem Cells / Q000166:cytology*; D006801:Humans; D007511:Ischemia / Q000628:therapy; D044968:Regenerative Medicine; D012984:Software; D014184:Transplantation, Homologous / Q000379:methods