The Effectiveness of Cord Blood Mononuclear CellsIntrathecal Injection on The Developmental Functions ofPatients with Spas tic Cerebral Palsy; Phase ۱ Clinical Trial

Objective: Cerebral palsy (CP) is the mos t common physicaldisability of children that results from non-progressive braininjuries. The current multi-center, randomized, double-blinds tudy was conducted among children with cerebral palsy to assessthe safety and efficacy of umbilical cord blood mononuclearcell (UCB-MNC).Materials and Methods: ۷۲ children with spas tic cerebral palsyaged ۴ to ۱۴ years were included in two of the experimentalor control groups. UCB-MNC cells group were injected at ۵ ×۱۰۶ per kg of child weight, Intrahecally. Primary and secondaryoutcomes were evaluated at ۱, ۳, ۶, and ۱۲ months after theintervention.Results: The mean GMFM-۶۶ scores increased in experimentalgroup; compared to baseline (+۹.۶۲; ۹۵%CI: ۶.۷۵, ۱۲.۴۹) andcontrol arm (β: ۷.۱۰; ۹۵%CI: ۲.۰۸, ۱۲.۷۶; Cohen's: ۰.۶۲) andmean MAS reduced in individuals treated with UCB-MNCscompared to the baseline (-۰.۸۷; ۹۵%CI: -۱.۲, -۰.۵۴) and controlgroup (β: -۰.۵۸; ۹۵%CI: -۱.۱۸, -۰.۱۱; Cohen’s d: ۰.۳۶).The mean PEDI scores and mean CP-QoL scores in the twodomains were higher in the experimental group compared tothe control. The imaging data indicated that mean FA increasedand MD decreased in participants of the UCB-MNC group indicatingimprovements in white matter s tructure. Lower backpain, headaches, and irritability were the mos t common adverseevents within ۲۴ h of treatment that were related to lumbarpuncture. No side effects were observed during follow-up.Conclusion: According to the results of this s tudy, UCB-MNCscan be effective in improving the motor function of cerebralpalsy and have the necessary safety.

کلیدواژه ها:

Cerebral Palsy ، Mononuclear Cells ، Umbilical CordBlood