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Safety and efficiency of Wharton’s Jelly-derived mesenchymal stem cell administration in patients with traumatic brain injury:First results of a phase I study

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World Journal of Stem Cells 2024年第6期16卷 641-655页

作者： Serdar Kabatas ErdinçCivelek Osman Boyalı gülseli berivan sezen Omer Ozdemir Yeliz Bahar-Ozdemir Necati Kaplan Eyüp Can Savrunlu Erdal Karaöz Department of Neurosurgery University of Health Sciences TurkeyGaziosmanpaşa Training and Research HospitalIstanbul 34360Türkiye Center for Stem Cell&gene Therapy Research and Practice University of Health Sciences TurkeyIstanbul 34255Türkiye Department of Neurosurgery University of Health SciencesGaziosmanpaşa Training and Research HospitalIstanbul 34255Türkiye Department of Physical Medicine and Rehabilitation Health Sciences University Sultan Abdulhamid Han Training and Research HospitalIstanbul 34668Türkiye Department of Neurosurgery Istanbul Rumeli UniversityÇorlu Reyap HospitalTekirdağ59860Türkiye Department of Neurosurgery Nevşehir State HospitalNevşehir 50300Türkiye Center for Regenerative Medicine and Stem Cell Research&Manufacturing(LivMedCell) Liv HospitalIstanbul 34340Türkiye Department of Histology and Embryology Istinye UniversityFaculty of MedicineIstanbul 34010Türkiye Center for Stem Cell and Tissue Engineering Research and Practice Istinye UniversityIstanbul 34340Türkiye

BACKgROUND Traumatic brain injury(TBI)is characterized by a disruption in the normal function of the brain due to an injury following a trauma,which can potentially cause severe physical,cognitive,and emotional *** cell transplantation has evolved as a novel treatment modality in the management of TBI,as it has the potential to arrest the degeneration and promote regeneration of new cells in the ***’s Jelly-derived mesenchymal stem cells(WJ-MSCs)have recently shown beneficial effects in the functional recovery of neurological *** To evaluate the safety and efficiency of MSC therapy in *** We present 6 patients,4 male and 2 female aged between 21 and 27 years who suffered a *** 6 patients underwent 6 doses of intrathecal,intramuscular(i.m.)and intravenous transplantation of WJ-MSCs at a target dose of 1×106/kg for each application *** was assessed using the Modified Ashworth scale(MAS),motor function according to the Medical Research Council Muscle Strength Scale,quality of life was assessed by the Functional Independence Measure(FIM)scale and Karnofsky Performance Status *** Our patients showed only early,transient complications,such as subfebrile fever,mild headache,and muscle pain due to ***,which resolved within 24 *** the one year follow-up,no other safety issues or adverse events were *** 6 patients showed improvements in their cognitive abilities,muscle spasticity,muscle strength,performance scores and fine motor skills when compared before and after the *** values,which we used to assess spasticity,were observed to statistically significantly decrease for both left and right sides(Pgnitive scores(Pgnificant increase in pretest posttest *** difference observed in the participants’Karnofsky Performance Scale values pre and post the intervention was statistically si

关键词： Traumatic brain injury Wharton Jelly Stem cell therapy Transplantation Mesenchymal stem cell

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Phase I study on the safety and preliminary efficacy of allogeneic mesenchymal stem cells in hypoxic-ischemic encephalopathy

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World Journal of Experimental Medicine 2021年第2期11卷 17-29页

作者： Serdar Kabataş ErdinçCivelek Necati Kaplan Eyüp Can Savrunlu gülseli berivan sezen Mourat Chasan Halil Can Ali genç Yener Akyuva Osman Boyalı Furkan Diren Erdal Karaoz Department of Neurosurgery University of Health SciencesGaziosmanpaşa Training and Research Hospitalİstanbul 34255Turkey Pediatric Allergy-Immunology Marmara UniversityInstitute of Health Sciencesİstanbul 34854Turkey Center for Stem Cell and gene Therapy Research and Practice University of Health Sciencesİstanbul 34255Turkey Department of Neurosurgery Istanbul Rumeli UniversityÇorlu Reyap HospitalTekirdağ59860Turkey Department of Neurosurgery İstanbul Biruni UniversityFaculty of Medicineİstanbul 34010Turkey Department of Neurosurgery İstanbul Medicine Hospitalİstanbul 34203Turkey Department of Neurosurgery İstanbul Asya Hospitalİstanbul 34250Turkey Department of Neurosurgery Mustafa Kemal UniversityFaculty of MedicineHatay 31060Turkey Center for Regenerative Medicine and Stem Cell Research and Manufacturing(LivMedCell) Liv Hospitalİstanbul 34340Turkey Department of Histology and Embryology İstinye UniversityFaculty of Medicineİstanbul 34010Turkey Center for Stem Cell and Tissue Engineering Research and Practice İstinye Universityİstanbul 34340Turkey

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.

关键词： Hypoxic-ischemic encephalopathy Stem cell Transplantation Wharton's jelly

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