title: Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy.
abstract: OBJECTIVE
  To assess feasibility and safety of providing autologous umbilical cord blood (UCB) cells to neonates with hypoxic-ischemic encephalopathy (HIE).
  
  
  METHODS
  We enrolled infants in the intensive care nursery who were cooled for HIE and had available UCB in an open-label study of non-cyropreserved autologous volume- and red blood cell-reduced UCB cells (up to 4 doses adjusted for volume and red blood cell content, 1-5 × 10(7) cells/dose). We recorded UCB collection and cell infusion characteristics, and pre- and post-infusion vital signs. As exploratory analyses, we compared cell recipients' hospital outcomes (mortality, oral feeds at discharge) and 1-year survival with Bayley Scales of Infant and Toddler Development, 3rd edition scores ≥85 in 3 domains (cognitive, language, and motor development) with cooled infants who did not have available cells.
  
  
  RESULTS
  Twenty-three infants were cooled and received cells. Median collection and infusion volumes were 36 and 4.3 mL. Vital signs including oxygen saturation were similar before and after infusions in the first 48 postnatal hours. Cell recipients and concurrent cooled infants had similar hospital outcomes. Thirteen of 18 (74%) cell recipients and 19 of 46 (41%) concurrent cooled infants with known 1-year outcomes survived with scores >85.
  
  
  CONCLUSIONS
  Collection, preparation, and infusion of fresh autologous UCB cells for use in infants with HIE is feasible. A randomized double-blind study is needed.
authors.affiliation: Department of Pediatrics, Duke University, Durham, NC. Electronic address: cotte010@mc.duke.edu.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Cotten
authors.affiliation: Department of Obstetrics and Gynecology, Duke University, Durham, NC.
authors.forename: Amy P
authors.initials: AP
authors.lastname: Murtha
authors.affiliation: Department of Pediatrics, Duke University, Durham, NC.
authors.forename: Ronald N
authors.initials: RN
authors.lastname: Goldberg
authors.affiliation: Department of Obstetrics and Gynecology, Duke University, Durham, NC.
authors.forename: Chad A
authors.initials: CA
authors.lastname: Grotegut
authors.affiliation: Department of Pediatrics, Duke University, Durham, NC.
authors.forename: P Brian
authors.initials: PB
authors.lastname: Smith
authors.affiliation: Department of Pediatrics, Duke University, Durham, NC.
authors.forename: Ricki F
authors.initials: RF
authors.lastname: Goldstein
authors.affiliation: Department of Pediatrics, Duke University, Durham, NC.
authors.forename: Kimberley A
authors.initials: KA
authors.lastname: Fisher
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC.
authors.forename: Kathryn E
authors.initials: KE
authors.lastname: Gustafson
authors.affiliation: Stem Cell Laboratory, Duke University Hospital, Durham, NC.
authors.forename: Barbara
authors.initials: B
authors.lastname: Waters-Pick
authors.affiliation: Department of Obstetrics and Gynecology, Duke University, Durham, NC.
authors.forename: Geeta K
authors.initials: GK
authors.lastname: Swamy
authors.affiliation: Department of Pediatrics, Duke University, Durham, NC.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Rattray
authors.affiliation: Department of Pediatrics, NorthShore University Health System and University of Chicago Pritzker School of Medicine, Chicago, IL.
authors.forename: Siddhartha
authors.initials: S
authors.lastname: Tan
authors.affiliation: Robertson Cell and Translational Therapy Program, Duke University, Durham, NC.
authors.forename: Joanne
authors.initials: J
authors.lastname: Kurtzberg
mesh_terms: D002675:Child, Preschool; D003131:Combined Modality Therapy; D036101:Cord Blood Stem Cell Transplantation / Q000379:methods*; D002658:Developmental Disabilities / Q000175:diagnosis / Q000209:etiology; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007036:Hypothermia, Induced; D020925:Hypoxia-Ischemia, Brain / Q000150:complications / Q000401:mortality / Q000601:surgery* / Q000628:therapy; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000401:mortality / Q000601:surgery / Q000628:therapy; D008297:Male; D010865:Pilot Projects; D012720:Severity of Illness Index; D014182:Transplantation, Autologous / Q000379:methods; D016896:Treatment Outcome