title: A policy for the disposal of autologous hematopoietic progenitor cells: report from an Italian consensus panel.
abstract: BACKGROUND
  Autologous stem cell transplantation (ASCT) requires collection and cryopreservation of hematopoietic progenitor cells (HPCs), which in turn may be partially or never reinfused. Thus, HPC storage has become a logistic, ethical, and economic issue. SIDEM, GITMO, and CNT/ISS endorsed a project aimed to define national criteria for HPC disposal aimed to guarantee appropriateness and equity.
  
  
  METHODS
  A multidisciplinary panel was convened including HPC harvest and manipulation experts from apheresis units, hematologists with clinical expertise in ASCT, a representative of the national health authority, and a bioethicist. An analytic hierarchy process (AHP) was carried out to select disposal criteria.
  
  
  RESULTS
  The AHP selected two criteria for prompt disposal of freshly collected HPCs: an abnormal freezing procedure causing highly reduced viability or major microbiology contamination. Moreover, AHP selected six major criteria, each one of them allowing for the disposal of stored HPC units: patient death, withdrawal of consent to ASCT, contraindications or loss of indications to ASCT, a damaged label that prevents correct identification of the unit, and time elapsed since harvest longer than 10 years. Three minor criteria were additionally identified that allowed to anticipate disposal only provided that viability levels are below the limit of acceptance: a documented cold chain interruption, loss of bag integrity, and total amount of stored CD34+ cells lower than 1 × 10(6) /kg or lower than 2 × 10(6)/kg in patients with a successfully completed stem cell transplantation program.
  
  
  CONCLUSIONS
  A formal consensus process allowed SIDEM and GITMO to propose a policy for autologous HPC disposal that fulfills clinical, ethical, and economic criteria.
authors.affiliation: Servizio di Immunoematologia e Trasfusionale, UOS Aferesi e Nuove Tecnologie Trasfusionali, A. O. San Gerardo, Monza, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Perseghin
authors.forename: Monia
authors.initials: M
authors.lastname: Marchetti
authors.forename: Luca
authors.initials: L
authors.lastname: Pierelli
authors.forename: Attilio
authors.initials: A
authors.lastname: Olivieri
authors.forename: Martino
authors.initials: M
authors.lastname: Introna
authors.forename: Letizia
authors.initials: L
authors.lastname: Lombardini
authors.forename: Patrizia
authors.initials: P
authors.lastname: Accorsi
authors.forename: Carlo
authors.initials: C
authors.lastname: Petrini
authors.forename: Marco
authors.initials: M
authors.lastname: Risso
authors.forename: Alberto
authors.initials: A
authors.lastname: Bosi
mesh_terms: D018380:Hematopoietic Stem Cell Transplantation / Q000331:legislation & jurisprudence*; D006412:Hematopoietic Stem Cells / Q000166:cytology*; D006801:Humans; D014182:Transplantation, Autologous / Q000331:legislation & jurisprudence*