Study design
BLOOD, ADVERSE EVENT
The previous RCT proceeded 12 months after receiving true or placebo study treatments for each patient. In the previous trial, participants were divided into four groups according to the intervention they were given: A) UCB + EPO, B) UCB + placebo EPO, C) placebo UCB + EPO, and D) placebo UCB + placebo EPO groups. Groups A and B were given allogeneic UCB units with 7 mg/kg bid per day of oral cyclosporine, while groups C and D were given placebos of UCB prepared from autologous peripheral blood and cyclosporine vehicle. Also, groups A and C were administered EPO (Espogen, LG Chem, Ltd., Korea) intravenously at a dose of 500 IU/kg at 2 h before UCB or placebo UCB infusion and 5 additional times subcutaneously starting from D + 3 at 3-day intervals. The outcomes were assessed with functional evaluations at baseline (T0) and 1 month (T1), 3 months (T3), 6 months (T6), and 12 months (T12) after the intervention [After the first trial, this extended study started 3 months after completion of the first trial, 15 months post-intervention (extension baseline, T15), for each patient perspective. The allocated group of the previous trial was still not open to the participants and study team until re-administration of the last enrolled participant at T15. In the present study, all patients received only allogeneic UCB infusion as an open label trial regardless of their initial allocation. Allogeneic UCB units were again selected from the affiliated CHA cord blood bank following approval of the National Institute of Organ, Tissue and Blood Management of Korea. TNC of each unit was counted when freezing the unit and the information was used for UCB unit selection and analyses in this study. Just before administration, each unit of UCB was washed to eliminate dimethyl sulfoxide according to an institutional protocol [The participants were followed for an additional 12 months. Adverse events (AEs) were carefully monitored. Outcome measures were the same as the primary outcomes of the previous trial: gross motor functional measure-66 (GMFM-66), gross motor performance measure (GMPM), and Bayley scales of infant development II (BSID-II) assessed at the extension baseline (T15) and 3 months (T18), 6 months (T21), and 12 months (T27) after the additional UCB infusion (T15) (Fig. Study timelineTo assess the effects of cell number, outcomes were analysed by TNC using correlation statistics after completion of the study. Since the median TNC number given for this trial was 4.4 × 10