{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Matsuyama N"],"funding":["Japan Agency for Medical Research and Development"],"pagination":["e057073"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9045108"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["12(4)"],"pubmed_abstract":["<h4>Introduction</h4>Neonatal hypoxic-ischaemic encephalopathy (HIE) is an important illness associated with death or cerebral palsy. This study aims to assess the safety and tolerability of the allogenic human multilineage-differentiating stress-enduring cell (Muse cell)-based product (CL2020) cells in newborns with HIE. This is the first clinical trial of CL2020 cells in neonates.<h4>Methods and analysis</h4>This is a single-centre, open-label, dose-escalation study enrolling up to 12 patients. Neonates with HIE who receive a course of therapeutic hypothermia therapy, which cools to a body temperature of 33°C-34°C for 72 hours, will be included in this study. A single intravenous injection of CL2020 cells will be administered between 5 and 14 days of age. Subjects in the low-dose and hig"],"journal":["BMJ open"],"pubmed_title":["Safety and tolerability of a multilineage-differentiating stress-enduring cell-based product in neonatal hypoxic-ischaemic encephalopathy with therapeutic hypothermia (SHIELD trial): a clinical trial protocol open-label, non-randomised, dose-escalation trial."],"pmcid":["PMC9045108"],"funding_grant_id":["JP21lm0203143"],"pubmed_authors":["Hirakawa A","Ueda K","Suzuki S","Suzuki T","Shimizu S","Matsuyama N","Miura R","Mizuno M","Katayama A","Hayakawa M","Ando M","Sato Y"],"additional_accession":[]},"is_claimable":false,"name":"Safety and tolerability of a multilineage-differentiating stress-enduring cell-based product in neonatal hypoxic-ischaemic encephalopathy with therapeutic hypothermia (SHIELD trial): a clinical trial protocol open-label, non-randomised, dose-escalation trial.","description":"<h4>Introduction</h4>Neonatal hypoxic-ischaemic encephalopathy (HIE) is an important illness associated with death or cerebral palsy. This study aims to assess the safety and tolerability of the allogenic human multilineage-differentiating stress-enduring cell (Muse cell)-based product (CL2020) cells in newborns with HIE. This is the first clinical trial of CL2020 cells in neonates.<h4>Methods and analysis</h4>This is a single-centre, open-label, dose-escalation study enrolling up to 12 patients. Neonates with HIE who receive a course of therapeutic hypothermia therapy, which cools to a body temperature of 33°C-34°C for 72 hours, will be included in this study. A single intravenous injection of CL2020 cells will be administered between 5 and 14 days of age. Subjects in the low-dose and hig","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Apr","modification":"2026-05-09T16:29:20.144Z","creation":"2025-04-05T15:57:59.536Z"},"accession":"S-EPMC9045108","cross_references":{"pubmed":["35473726"],"doi":["10.1136/bmjopen-2021-057073"]}}