Discussion
T15
GROUP B
This study aimed to identify the therapeutic efficacies of UCB and EPO over a longer period when there were additional treatments with only allogeneic UCB among children with CP who participated in a previous RCT [Before analysing the efficacy results, data on safety should be reviewed. As in previous trials [With respect to efficacy, the overall therapeutic effect of allogeneic UCB infusion was low in this study. Our previous trials showed potentiated therapeutic efficacy of allogeneic UCB with coadministration of EPO [Intergroup differences were not found at the last follow-up compared to the extension baseline, T15, and Groups A and B, who received UCB twice, showed only trends of larger improvements without significance. Moreover, when comparing each 12-month interval functional outcome at the first trial (T0 to T12) and the extended study (T15 to T27) in Group B, which undertook the same procedure administering UCB only, improvement at the first trial almost trebled that in the extended study regarding the GMFM-66 score (5.69 Additionally, the number of TNCs can be regarded as a second important factor for therapeutic efficacy in UCB cell therapy. The mean TNC per kg was 4.4 × 10Unlike our hypothesis, multiple dosages of UCB did not show significantly accumulated clinical efficacy. Although the GMFM-66 and GMFM-66 change ratios showed a tendency of greater effects in Groups A and B compared to Groups C and D, the statistics did not reveal significance. We suppose this is due to the long-term interval between the first and the second infusion, which was as long as almost 15 months. In most other trials where multiple dosages of therapeutic cells were given to children with CP, the intervals were much shorter. In two reports from a Chinese group, multiple cord blood mesenchymal stem cell infusions were administered eight times, twice every day [This trial had some limitations. As it was the extension study of the previous trial [