ABSTRACT
INTRODUCTION: The current multi-center, randomized, double-blind study was conducted among children with cerebral palsy (CP) to assess the safety and efficacy of umbilical cord blood mononuclear cell (UCB-MNC). We performed the diffusion tensor imaging to assess the changes in the white matter structure. METHODS: Males and females aged 4 to 14 years old with spastic CP were included. Eligible participants were allocated in 4:1 ratio to be in the experimental or control groups; respectively. Individuals who were assigned in UCB-MNC group were tested for human leukocyte antigen (HLA) and fully-matched individuals were treated with UCB-MNCs. A single dose (5 × 106 /kg) UCB-MNCs were administered via intrathecal route in experimental group. The changes in gross motor function measure (GMFM)-66 from baseline to one year after treatment were the primary endpoints. The mean changes in modified Ashworth scale (MAS), pediatric evaluation of disability inventory (PEDI), and CP quality of life (CP-QoL) were also evaluated and compared between groups. The mean changes in fractional anisotropy (FA) and mean diffusivity (MD) of corticospinal tract (CST) and posterior thalamic radiation (PTR) were the secondary endpoints. Adverse events were safety endpoint. RESULTS: There were 72 included individuals (36 cases in each group). The mean GMFM-66 scores increased in experimental group; compared to baseline (+ 9.62; 95%CI: 6.75, 12.49) and control arm (ß: 7.10; 95%CI: 2.08, 12.76; Cohen's d: 0.62) and mean MAS reduced in individuals treated with UCB-MNCs compared to the baseline (-0.87; 95%CI: -1.2, -0.54) and control group (ß: -0.58; 95%CI: -1.18, -0.11; Cohen's d: 0.36). The mean PEDI scores and mean CP-QoL scores in two domains were higher in the experimental group compared to the control. The imaging data indicated that mean FA increased and MD decreased in participants of UCB-MNC group indicating improvements in white matter structure. Lower back pain, headaches, and irritability were the most common adverse events within 24 h of treatment that were related to lumbar puncture. No side effects were observed during follow-up. CONCLUSIONS: This trial showed that intrathecal injection of UCB-MNCs were safe and effective in children with CP. TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov ( NCT03795974 ).
Subject(s)
Cerebral Palsy , Adolescent , Child , Child, Preschool , Diffusion Tensor Imaging/methods , Double-Blind Method , Female , Fetal Blood , Humans , Male , Quality of LifeABSTRACT
White spot lesions (WSLs) are one of the adverse effects of fixed orthodontic treatments. They are the primary sign of caries, which means inhibiting this process by antibacterial agents will reverse the procedure. The current study tested the surface modification of nickel-titanium (NiTi) wires with ZnO nanoparticles (NPs), as antimicrobial agents. As the morphology of NPs is one of the most critical factors for their properties, the antibacterial properties of different morphologies of ZnO nanostructures coated on the NiTi wire were investigated. For the preparation of ZnO nanostructures, five coating methods, including chemical vapor deposition (CVD), chemical precipitation method, polymer composite coating, sol-gel synthesis, and electrospinning process, were used. The antibacterial activity of NPs was assessed against Streptococcus mutans by the colony counting method. The obtained results showed that all the samples had antibacterial effects. The antibacterial properties of ZnO NPs were significantly improved when the specific surface area of particles increased, by the ZnO nanocrystals prepared via the CVD coating method.
