title: Chromosomal stability of mesenchymal stromal cells during in vitro culture.
abstract: OBJECTIVE
  Mesenchymal stromal cells (MSCs) are being investigated for use in cell therapy. The extensive in vitro expansion necessary to obtain sufficient cells for clinical use increases the risk that genetically abnormal cells will arise and be propagated during cell culture. Genetic abnormalities may lead to transformation and poor performance in clinical use, and are a critical safety concern for cell therapies using MSCs.
  
  
  METHODS
  We used spectral karyotyping (SKY) to investigate the genetic stability of human MSCs from ten donors during passaging.
  
  
  RESULTS
  Our data indicate that chromosomal abnormalities exist in MSCs at early passages and can be clonally propagated. The karyotypic abnormalities observed during our study diminished during passage.
  
  
  CONCLUSIONS
  Karyotyping of MSCs reveals characteristics which may be valuable in deciding the suitability of cells for further use. Karyotypic analysis is useful for monitoring the genetic stability of MSCs during expansion.
authors.affiliation: Division of Cell and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Brian G
authors.initials: BG
authors.lastname: Stultz
authors.affiliation: Division of Cell and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: McGinnis
authors.affiliation: Division of Cell and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Elaine E
authors.initials: EE
authors.lastname: Thompson
authors.affiliation: Division of Cell and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Jessica L
authors.initials: JL
authors.lastname: Lo Surdo
authors.affiliation: Division of Cell and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Bauer
authors.affiliation: Division of Cell and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. Electronic address: deborah.hursh@fda.hhs.gov.
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Hursh
mesh_terms: D000328:Adult; D001854:Bone Marrow Cells / Q000166:cytology / Q000502:physiology; D018929:Cell Culture Techniques; D064987:Cell- and Tissue-Based Therapy; D002478:Cells, Cultured; D043171:Chromosomal Instability / Q000502:physiology*; D002869:Chromosome Aberrations; D002999:Clone Cells; D005260:Female; D006801:Humans; D007621:Karyotyping; D008297:Male; D059630:Mesenchymal Stem Cells / Q000166:cytology* / Q000378:metabolism* / Q000502:physiology; D055815:Young Adult
keywords: MSC; SKY; genomic stability; mesenchymal stromal cells; spectral karyotyping