title: Clinical Evaluation of the Safety and Feasibility of Whole Autologous Cord Blood Transplant as a Source of Stem and Progenitor Cells for Extremely Premature Neonates: Preliminary Report.
abstract: OBJECTIVE
  This is a preliminary, single-center, prospective study in the field of autologous cord blood transplant. We investigated the feasibility, safety, and tolerability of autologous whole cord blood transplant in extremely premature infants as a potential therapeutic modality to prevent developing complications related to prematurity.
  
  
  METHODS
  This preliminary prospective study (ClinicalTrials.gov identifier NCT02050971) included preterm infants born at less than 32 weeks of gestational age who developed anemia because of prematurity. Infants were assigned to 2 groups: (1) those receiving an autologous cord blood transfusion within 5 days postpartum (n = 5) and (2) those who obtained only an allogeneic red blood cell transfusion when necessary (n = 9; control group). Vital measurements were performed during and after transfusion, and peripheral blood pH, hematocrit, glucose, and calcium and potassium ion levels were measured over the next 4 days.
  
  
  RESULTS
  Oxygen saturation was significantly increased throughout the cord blood transfusion and in the subsequent 48 hours. No significant differences were found in vital measurements, such as arterial blood pressure (mean, systolic, and diastolic) or heart rate over the first 48 hours posttransfusion. Similarly, no significant differences were found in biochemical analyses of blood with the exception of pH level. We found initial pH level to be significantly augmented in the cord blood recipient group by the first day after transplant, which remained significantly higher for next 24 hours compared with that shown in the control group.
  
  
  CONCLUSIONS
  Collection, preparation, and short-term storage of unfrozen cord blood are feasible for clinical use. Our results showed general safety and tolerability of the procedure of whole autologous cord blood transplant in recruited preterm newborns. However, because our study group was small, these results need to be confirmed in further investigations with a larger patient cohort.
authors.affiliation: Department of Humanities in Medicine, Pomeranian Medical University in Szczecin, 70-111 Szczecin, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Rudnicki
authors.forename: Miłosz Piotr
authors.initials: MP
authors.lastname: Kawa
authors.forename: Maciej
authors.initials: M
authors.lastname: Kotowski
authors.forename: Barbara
authors.initials: B
authors.lastname: Michalczyk
authors.forename: Przemysław
authors.initials: P
authors.lastname: Ustianowski
authors.forename: Ryszard
authors.initials: R
authors.lastname: Czajka
authors.forename: Bogusław
authors.initials: B
authors.lastname: Machaliński
mesh_terms: D036101:Cord Blood Stem Cell Transplantation; D017707:Erythrocyte Transfusion; D005312:Fetal Blood / Q000637:transplantation*; D006801:Humans; D062071:Infant, Extremely Premature / Q000502:physiology*; D007231:Infant, Newborn; D011446:Prospective Studies; D033581:Stem Cell Transplantation / Q000379:methods*; D014182:Transplantation, Autologous