Clinical procedure of cell therapy: Cord blood collection

Abstract

The safety and efficacy of providing umbilical cord blood (UCB) cells to neonates with hypoxic-ischemic encephalopathy (HIE) have recently been reported in the United States (Michael et al. J Pediatr 164: 973-979, 2014). We have thus decided to initiate a similar clinical trial in Japan and set obstetric criteria for the indication of cell therapy. Written consent for UCB collection was obtained following successful collection, as the cases included in the study were very limited. Because UCB cells are first administered to neonates 24 h after collection, a more stringent level of aseptic manipulation is required although UCB collection itself is a common procedure in Japan. Therefore, UCB collection was performed ex utero at the proximal end of the umbilical cord because the umbilical vein offers a steady site of puncture at this point, enabling reproducible aseptic UCB collection.