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
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نویسندگان

M Nouri

Department of Research and Development, Royan S tem CellTechnology Company, Cord Blood Bank, Tehran, Iran

M Zarrabi

Department of Regenerative Medicine, Cell Science ResearchCenter, Royan Ins titute for S tem Cell Biology and Technology,ACECR, Tehran, Iran

A Majmaa

Pediatrics Center of Excellence, Pediatric Intensive Unit, Children’sMedical Center, Tehran University of Medical Sciences, Tehran,Iran

M Ghahvechi Akbari

Physical Medicine and Rehabilitation Department, Children’sMedical Center, Tehran University of Medical Sciences, Tehran, Iran

E Dehghan

Department of Transplantation, Royan S tem Cell TechnologyCompany, Tehran, Iran

S Abroun

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 CordBlood

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