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

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dc.authoridErdal Karaöz / 0000-0002-9992-833Xen_US
dc.authorscopusidErdal Karaöz / 7003448087
dc.authorwosidErdal Karaöz / IXE-6677-2023
dc.contributor.authorKabataş, Serdar
dc.contributor.authorCivelek, Erdinç
dc.contributor.authorKaplan, Necati
dc.contributor.authorSavrunlu, Eyüp Can
dc.contributor.authorSezen, Gülseli Berivan
dc.contributor.authorChasan, Mourat
dc.contributor.authorCan, Halil
dc.contributor.authorGenç, Ali
dc.contributor.authorAkyuva, Yener
dc.contributor.authorBoyalı, Osman
dc.contributor.authorDiren, Furkan
dc.contributor.authorKaraöz, Erdal
dc.date.accessioned2021-05-04T09:57:20Z
dc.date.available2021-05-04T09:57:20Z
dc.date.issued2021en_US
dc.departmentİstinye Üniversitesi, Tıp Fakültesi, Temel Tıp Bilimleri Bölümüen_US
dc.description.abstractBACKGROUND 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 dysfunctionality. AIM To investigate the safety and preliminary efficacy of allogeneic mesenchymal stem cells (MSCs) in HIE patients. METHODS Patients who had HIE for at least 6 mo along with significant dysfunction and disability were included. All patients were given Wharton's jelly-derived MSCs at 1 × 106/kg intrathecally, intravenously, and intramuscularly twice a month for two months. The therapeutic effects and prognostic implications of MSCs were evaluated by multiple follow-ups. Functional independence measure (FIM), modified Ashworth, and Karnofsky scales were used to assess any side effects, neurological and cognitive functions, and overall outcomes. RESULTS The 8 subjects included in the study had a mean age of 33.25 ± 10.18 years. Mean HIE exposure and mean post-HIE durations were 45.63 ± 10.18 and 19.67 ± 29.04 mo, respectively. Mean FIM score was 18.38 ± 1.06, mean modified Ashworth score was 43.5 ± 4.63, and mean Karnofsky score was 20. For 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 administration. Neurological and functional examinations, laboratory tests, electroencephalography, and magnetic resonance imaging were performed to assess safety of treatment. Mean 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 mo. CONCLUSION Multiple triple-route Wharton's jelly-derived MSC administrations were found to be safe for HIE patients, indicating neurological and functional improvement. Based on the findings obtained here, further randomized and placebo research could be performed.en_US
dc.identifier.citationKabataş, S., Civelek, E., Kaplan, N., Savrunlu, E. C., Sezen, G. B., Chasan, M., ... & Karaoz, E. (2021). Phase I study on the safety and preliminary efficacy of allogeneic mesenchymal stem cells in hypoxic-ischemic encephalopathy. World Journal of Experimental Medicine, 11(2), 17.en_US
dc.identifier.doi10.5493/WJEM.V11.I2.17en_US
dc.identifier.endpage29en_US
dc.identifier.issn2220-315Xen_US
dc.identifier.issue2en_US
dc.identifier.scopus2-s2.0-85104399097en_US
dc.identifier.scopusqualityQ4en_US
dc.identifier.startpage17en_US
dc.identifier.urihttps://www.doi.org/10.5493/WJEM.V11.I2.17
dc.identifier.urihttps://hdl.handle.net/20.500.12713/1720
dc.identifier.volume11en_US
dc.indekslendigikaynakScopusen_US
dc.institutionauthorKaraöz, Erdal
dc.language.isoenen_US
dc.publisherBaishideng Publishing Group Coen_US
dc.relation.ispartofWorld Journal of Experimental Medicineen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectHypoxic-Ischemic Encephalopathyen_US
dc.subjectStem Cellen_US
dc.subjectTransplantationen_US
dc.subjectWharton's Jellyen_US
dc.titlePhase I study on the safety and preliminary efficacy of allogeneic mesenchymal stem cells in hypoxic-ischemic encephalopathyen_US
dc.typeArticleen_US

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