Clinical procedure of cell therapy: Separation and infusion

Abstract

Umbilical cord blood (UCB) cells could be a useful adjunct intervention for infants with HIE. We report our clinical experience of UCB stem cell transplantation in infants with HIE. We selected patients for UCB stem cell transplantation based on following criteria; (1) moderate or severe HIE according to the classification of Sarnat II or III and Thompson score ≥ 10 points, (2) gestational age ≥ 36 weeks, (3) body weight at birth > 1800 g, (4) born by cesarean section under general anesthesia, and (5) inborn baby. Cases in which collected UCB volume is below 40 mL were excluded from this trial. Brain hypothermia therapy (BHT) was performed simultaneously under supportive mechanical ventilation with sedative agents (fentanyl citrate and midazolam). After collected UCB, CD34-positive cells were separated by SEPAX-2™ (Biosafe SA, Eysins/Nyon, Switzerland) and were transfused to the babies once a day for 12 h to 3 days. This treatment was successful and safe in all three cases with no adverse effects. A randomized phase II study to provide further safety, feasibility, and efficacy information among a wider number of sites is warranted.