Feasibility of allogeneic mesenchymal stem cells in pediatric hypoxic-ischemic encephalopathy: Phase I study

作     者：Serdar Kabatas Erdinç Civelek Eyüp Can Savrunlu Necati Kaplan Osman Boyalı Furkan Diren Halil Can Ali Genç Tunç Akkoç Erdal Karaöz 

作者机构：Department of NeurosurgeryUniversity of Health SciencesGaziosmanpaşa Training and Research HospitalIstanbul 34255Turkey Pediatric Allergy-ImmunologyMarmara UniversityInstitute of Health SciencesIstanbul 34854Turkey Center for Stem Cell&Gene Therapy Research and PracticeUniversity of Health SciencesIstanbul 34255Turkey Department of NeurosurgeryIstanbul Rumeli UniversityÇorlu Reyap HospitalTekirdağ59860Turkey Department of NeurosurgeryIstanbul Biruni UniversityFaculty of MedicineIstanbul 34010Turkey Department of NeurosurgeryIstanbul Medicine HospitalIstanbul 34203Turkey Department of NeurosurgeryIstanbul Asya HospitalIstanbul 34250Turkey Pediatric Allergy-ImmunologyMarmara UniversityIstanbul 34899Turkey Center for Regenerative Medicine and Stem Cell Research&Manufacturing(LivMedCell)Liv HospitalIstanbul 34340Turkey Department of Histology and EmbryologyIstinye UniversityFaculty of MedicineIstanbul 34010Turkey Center for Stem Cell and Tissue Engineering Research and PracticeIstinye UniversityIstanbul 34340Turkey 

出 版 物：《World Journal of Stem Cells》 (世界干细胞杂志（英文版）（电子版）)

年 卷 期：2021年第13卷第5期

页      面：470-484页

核心收录：

学科分类：1002[医学-临床医学] 1010[医学-医学技术（可授医学、理学学位）] 100204[医学-神经病学] 100215[医学-康复医学与理疗学] 10[医学] 

主　　题：Hypoxic-ischemic encephalopathy Pediatric Stem cell Wharton jelly 

摘      要：BACKGROUND Hypoxic-ischemic encephalopathy(HIE)is one of the leading causes of death and long-term neurological impairment in the pediatric *** a limited number of treatments to cure HIE,stem cell therapies appear to be a potential treatment option for brain injury resulting from *** To investigate the efficacy and safety of stem cell-based therapies in pediatric patients with *** The study inclusion criteria were determined as the presence of substantial deficit and disability caused by ***’s jelly-derived mesenchymal stem cells(WJ-MSCs)were intrathecally(IT),intramuscularly(IM),and intravenously administered to participants at a dose of 1×10^(6)/kg for each administration route twice monthly for 2 *** different follow-up durations,the effect of WJ-MSCs administration on HIE,the quality of life,prognosis of patients,and side effects were investigated,and patients were evaluated for neurological,cognitive functions,and spasticity using the Wee Functional Independence Measure(Wee FIM)Scale and Modified Ashworth(MA)*** For all participants(n=6),the mean duration of exposure to hypoxia was 39.17+18.82 min,the mean time interval after HIE was 21.83±26.60 mo,the mean baseline Wee FIM scale score was 13.5±0.55,and the mean baseline MA scale score was 35±*** patients developed only early complications such as low-grade fever,mild headache associated with IT injection,and muscle pain associated with IM injection,all of which were transient and disappeared within 24 *** treatment was evaluated to be safe and effective as demonstrated by magnetic resonance imaging examinations,electroencephalographies,laboratory tests,and neurological and functional scores of *** exhibited significant improvements in all neurological functions through a 12-mo *** mean Wee FIM scale score of participants increased from 13.5±0.55 to 15.17±1.6 points(mean±SD)at 1 mo(z=-1.826,P=0.068)and to 23.5±3.39 points at 12 mo(z