The Effectiveness of Cord Blood Mononuclear CellsIntrathecal Injection on The Developmental Functions ofPatients with Spas tic Cerebral Palsy; Phase ۱ Clinical Trial
- سال انتشار: 1401
- محل انتشار: بیست و سومین کنگره بین المللی هیبریدی پزشکی تولید مثل و هجدهمین کنگره هیبریدی فناوری سلولهای بنیادی رویان
- کد COI اختصاصی: RROYAN23_281
- زبان مقاله: انگلیسی
- تعداد مشاهده: 154
نویسندگان
Department of Research and Development, Royan S tem CellTechnology Company, Cord Blood Bank, Tehran, Iran
Department of Regenerative Medicine, Cell Science ResearchCenter, Royan Ins titute for S tem Cell Biology and Technology,ACECR, Tehran, Iran
Pediatrics Center of Excellence, Pediatric Intensive Unit, Children’sMedical Center, Tehran University of Medical Sciences, Tehran,Iran
Physical Medicine and Rehabilitation Department, Children’sMedical Center, Tehran University of Medical Sciences, Tehran, Iran
Department of Transplantation, Royan S tem Cell TechnologyCompany, Tehran, Iran
Department of Hematology, Faculty of Medical Sciences, TarbiatModares University, Tehran, Iran
چکیده
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 CordBloodاطلاعات بیشتر در مورد COI
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