Phase I study on the safety and preliminary efficacy of allogeneic mesenchymal stem cells in hypoxic-ischemic encephalopathy
作者机构：Department of NeurosurgeryUniversity of Health SciencesGaziosmanpaşa Training and Research Hospitalİstanbul 34255Turkey Pediatric Allergy-ImmunologyMarmara UniversityInstitute of Health Sciencesİstanbul 34854Turkey Center for Stem Cell and Gene Therapy Research and PracticeUniversity of Health Sciencesİstanbul 34255Turkey Department of NeurosurgeryIstanbul Rumeli UniversityÇorlu Reyap HospitalTekirdağ59860Turkey Department of Neurosurgeryİstanbul Biruni UniversityFaculty of Medicineİstanbul 34010Turkey Department of Neurosurgeryİstanbul Medicine Hospitalİstanbul 34203Turkey Department of Neurosurgeryİstanbul Asya Hospitalİstanbul 34250Turkey Department of NeurosurgeryMustafa Kemal UniversityFaculty of MedicineHatay 31060Turkey Center for Regenerative Medicine and Stem Cell Research and Manufacturing(LivMedCell)Liv Hospitalİstanbul 34340Turkey Department of Histology and Embryologyİstinye UniversityFaculty of Medicineİstanbul 34010Turkey Center for Stem Cell and Tissue Engineering Research and Practiceİstinye Universityİstanbul 34340Turkey
出 版 物：《World Journal of Experimental Medicine》 (世界实验医学杂志)
年 卷 期：2021年第11卷第2期
页 面：17-29页
学科分类：1002[医学-临床医学] 100202[医学-儿科学] 10[医学]
主 题：Hypoxic-ischemic encephalopathy Stem cell Transplantation Wharton's jelly
摘 要：BACKGROUND Hypoxic-ischemic encephalopathy(HIE)is a leading cause of morbidity and mortality in the adult as well as in the neonate,with limited options for treatment and significant *** To investigate the safety and preliminary efficacy of allogeneic mesenchymal stem cells(MSCs)in HIE *** Patients who had HIE for at least 6 mo along with significant dysfunction and disability were *** patients were given Wharton’s jelly-derived MSCs at 1×106/kg intrathecally,intravenously,and intramuscularly twice a month for two *** therapeutic effects and prognostic implications of MSCs were evaluated by multiple *** independence measure(FIM),modified Ashworth,and Karnofsky scales were used to assess any side effects,neurological and cognitive functions,and overall *** The 8 subjects included in the study had a mean age of 33.25±10.18 *** HIE exposure and mean post-HIE durations were 45.63±10.18 and 19.67±29.04 mo,*** FIM score was 18.38±1.06,mean modified Ashworth score was 43.5±4.63,and mean Karnofsky score was *** the first 24 h,5 of the patients experienced a subfebrile state,accompanied by mild headaches due to intrathecally administration and muscle pain because of intramuscularly *** and functional examinations,laboratory tests,electroencephalography,and magnetic resonance imaging were performed to assess safety of *** FIM score increased by 20.88±3.31 in the first month(P=0.027)and by 31.38±14.69 in 12 mo(P=0.012).The rate of patients with an FIM score of 126 increased from 14.58%to 16.57%in the first month and 24.90%in 12 *** Multiple triple-route Wharton’s jelly-derived MSC administrations were found to be safe for HIE patients,indicating neurological and functional *** on the findings obtained here,further randomized and placebo research could be performed.
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