title: Umbilical cord blood therapy potentiated with erythropoietin for children with cerebral palsy: a double-blind, randomized, placebo-controlled trial.
abstract: Allogeneic umbilical cord blood (UCB) has therapeutic potential for cerebral palsy (CP). Concomitant administration of recombinant human erythropoietin (rhEPO) may boost the efficacy of UCB, as it has neurotrophic effects. The objectives of this study were to assess the safety and efficacy of allogeneic UCB potentiated with rhEPO in children with CP. Children with CP were randomly assigned to one of three parallel groups: the pUCB group, which received allogeneic UCB potentiated with rhEPO; the EPO group, which received rhEPO and placebo UCB; and the Control group, which received placebo UCB and placebo rhEPO. All participants received rehabilitation therapy. The main outcomes were changes in scores on the following measures during the 6 months treatment period: the gross motor performance measure (GMPM), gross motor function measure, and Bayley scales of infant development-II (BSID-II) Mental and Motor scales (18). F-fluorodeoxyglucose positron emission tomography (18F-FDG-PET/CT) and diffusion tensor images (DTI) were acquired at baseline and followed up to detect changes in the brain. In total, 96 subjects completed the study. Compared with the EPO (n = 33) and Control (n = 32) groups, the pUCB (n = 31) group had significantly higher scores on the GMPM and BSID-II Mental and Motor scales at 6 months. DTI revealed significant correlations between the GMPM increment and changes in fractional anisotropy in the pUCB group. 18F-FDG-PET/CT showed differential activation and deactivation patterns between the three groups. The incidence of serious adverse events did not differ between groups. In conclusion, UCB treatment ameliorated motor and cognitive dysfunction in children with CP undergoing active rehabilitation, accompanied by structural and metabolic changes in the brain.
authors.affiliation: Department of Rehabilitation Medicine, CHA University, Seongnam-si, Gyeonggi-do, Korea. kmin@cha.ac.kr
authors.forename: Kyunghoon
authors.initials: K
authors.lastname: Min
authors.forename: Junyoung
authors.initials: J
authors.lastname: Song
authors.forename: Jin Young
authors.initials: JY
authors.lastname: Kang
authors.forename: Jooyeon
authors.initials: J
authors.lastname: Ko
authors.forename: Ju Seok
authors.initials: JS
authors.lastname: Ryu
authors.forename: Myung Seo
authors.initials: MS
authors.lastname: Kang
authors.forename: Su Jin
authors.initials: SJ
authors.lastname: Jang
authors.forename: Sang Heum
authors.initials: SH
authors.lastname: Kim
authors.forename: Doyeun
authors.initials: D
authors.lastname: Oh
authors.forename: Moon Kyu
authors.initials: MK
authors.lastname: Kim
authors.forename: Sung Soo
authors.initials: SS
authors.lastname: Kim
authors.forename: Minyoung
authors.initials: M
authors.lastname: Kim
mesh_terms: D002547:Cerebral Palsy / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004921:Erythropoietin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005312:Fetal Blood / Q000637:transplantation*; D019788:Fluorodeoxyglucose F18; D006801:Humans; D007223:Infant; D008297:Male; D010919:Placebos; D049268:Positron-Emission Tomography / Q000379:methods; D019275:Radiopharmaceuticals; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18; D004921:Erythropoietin