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

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

Introduction 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 new...

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Bibliografiske detaljer
Main Authors:	Akihiro Hirakawa, Masahiko Ando, Masahiro Hayakawa, Nao Matsuyama, Shinobu Shimizu, Kazuto Ueda, Toshihiko Suzuki, Sakiko Suzuki, Ryosuke Miura, Akemi Katayama, Masaaki Mizuno, Yoshiaki Sato
Format:	Article
Sprog:	English
Udgivet:	BMJ Publishing Group 2022-04-01
Serier:	BMJ Open
Online adgang:	https://bmjopen.bmj.com/content/12/4/e057073.full

Lignende værker

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af: Kazuto Ueda, et al.
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Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data
af: Edwards, A, et al.
Udgivet: (2010)

Incidence of hypoxic-ischaemic encephalopathy and use of therapeutic hypothermia in Spain
af: Juan Arnaez, et al.
Udgivet: (2018-07-01)

Assessment of brain tissue injury after moderate hypothermia in neonates with hypoxic-ischaemic encephalopathy: a nested substudy of a randomised controlled trial.
af: Rutherford, M, et al.
Udgivet: (2010)

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af: Donna Lei, et al.
Udgivet: (2021-11-01)

THE EXPERIENCE OF USING LOW-TECHNOLOGY HYPOTHERMIA IN THE NEWBORN WITH SEVERE HYPOXIC ISCHAEMIC ENCEPHALOPATHY
af: A. A. Zadvornov, et al.
Udgivet: (2017-12-01)

Pharmacokinetics during therapeutic hypothermia for neonatal hypoxic ischaemic encephalopathy: a literature review
af: Karel Allegaert, et al.
Udgivet: (2020-02-01)

The Neural Multilineage Differentiation Capacity of Human Neural Precursors from the Umbilical Cord—Ready to Bench for Clinical Trials
af: Daiany de Souza Dobuchak, et al.
Udgivet: (2022-09-01)

Pragmatic dose-escalation methods incorporating relative dose intensity assessment for molecularly targeted agents in phase I trials
af: Akihiro Hirakawa, et al.
Udgivet: (2019-12-01)

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af: Christian Huber, et al.
Udgivet: (2019-01-01)

Therapeutic hypothermia for neonatal hypoxic ischaemic encephalopathy in Sub-Saharan Africa: A scoping review.
af: Naa A Buxton-Tetteh, et al.
Udgivet: (2025-01-01)

Physiological responses to cuddling babies with hypoxic–ischaemic encephalopathy during therapeutic hypothermia: an observational study
af: Marianne Thoresen, et al.
Udgivet: (2021-10-01)

Correction: Passive hypothermia (≥35 - <36°C) during transport of newborns with hypoxic-ischaemic encephalopathy.
af: Aurélie Sellam, et al.
Udgivet: (2017-01-01)

Dedifferentiation of human primary thyrocytes into multilineage progenitor cells without gene introduction.
af: Keiji Suzuki, et al.
Udgivet: (2011-01-01)

Therapeutic hypothermia after recanalisation in patients with acute ischaemic stroke
af: Ranadhir Mitra
Udgivet: (2014-05-01)

Mobilization of multilineage-differentiating stress-enduring cells into the peripheral blood in liver surgery.
af: Koji Kikuchi, et al.
Udgivet: (2022-01-01)

The duration of hypothermia affects short-term neuroprotection in a mouse model of neonatal hypoxic ischaemic injury.
af: Eridan Rocha-Ferreira, et al.
Udgivet: (2018-01-01)

Therapeutic hypothermia increases the risk of cardiac arrhythmia for perinatal hypoxic ischaemic encephalopathy: A meta-analysis.
af: Wei Zhang, et al.
Udgivet: (2017-01-01)

Treatment planning of dose escalation for anal cancer in the PLATO trial
af: Abbott, N, et al.
Udgivet: (2017)

Dose Escalation Trial of Desulfated Heparin (ODSH) in Septic Peritonitis
af: Katie D. Mauro, et al.
Udgivet: (2022-04-01)

Remote ischaemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischaemic stroke a randomised trial
af: Ranadhir Mitra
Udgivet: (2014-05-01)

Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke
af: Per Winkel, et al.
Udgivet: (2017-11-01)

Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)
af: Agnethe Eltoft, et al.
Udgivet: (2022-05-01)

Review of a frugal cooling mattress to induce therapeutic hypothermia for treatment of hypoxic-ischaemic encephalopathy in the UK NHS
af: Giulia Dallera, et al.
Udgivet: (2022-04-01)

Therapeutic Hypothermia for Hypoxic Ischaemic Encephalopathy in Singapore General Hospital: Two Patient Case Series and Review of Literature
af: Sridhar Arunachalam MD, MRCPCH (UK), et al.
Udgivet: (2012-12-01)

Therapeutic hypothermia for acute ischaemic stroke: Interventional procedures guidance [IPG647]
af: Powell, J, et al.
Udgivet: (2019)

Impact of Erythropoietin in the management of Hypoxic Ischaemic Encephalopathy in resource-constrained settings: protocol for a randomized control trial
af: Beatrice Ezenwa, et al.
Udgivet: (2020-05-01)

Hypothermia for perinatal asphyxia: trial-based quality of life at 6–7 years
af: Campbell, H, et al.
Udgivet: (2018)

Updates on Selective Brain Hypothermia: Studies From Bench Work to Clinical Trials
af: Xiaoyu Wang, et al.
Udgivet: (2022-05-01)

Seminoma and dysgerminoma: evidence for alignment of clinical trials and de-escalation of systemic chemotherapy
af: Georgina E. Wood, et al.
Udgivet: (2023-10-01)

A phase I dose-escalation trial of stereotactic body radiotherapy using 4 fractions for patients with localized prostate cancer
af: Takuro Kainuma, et al.
Udgivet: (2019-09-01)

Master protocol trials in oncology: Review and new trial designs
af: Akihiro Hirakawa, et al.
Udgivet: (2018-12-01)

Trial of remote ischaemic preconditioning in vascular cognitive impairment (TRIC-VCI): protocol
af: Aravind Ganesh, et al.
Udgivet: (2020-10-01)

The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke
af: Cantisani Teresa, et al.
Udgivet: (2008-06-01)

Early versus delayed enteral nutrition for neonatal hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia: a randomized controlled trial
af: Ya Hu, et al.
Udgivet: (2022-08-01)

Design of a Randomized Controlled Clinical Study of tissue-engineered osteogenic materials using bone marrow-derived mesenchymal cells for Maxillomandibular bone defects in Japan: the TEOM study protocol
af: Shinobu Shimizu, et al.
Udgivet: (2019-04-01)

Hypothermia for perinatal asphyxia: trial-based resource use and costs at 6 to 7 years
af: Rivero Arias, O, et al.
Udgivet: (2018)

Hypothermia during partial nephrectomy for patients with renal tumors: a randomized controlled trial
af: Breau, RH, et al.
Udgivet: (2020)

Hypothermia for traumatic brain injury in children - A phase II randomized controlled trial
af: Barkha Bindu, et al.
Udgivet: (2016-01-01)

Human adipose tissue-derived multilineage progenitor cells exposed to oxidative stress induce neurite outgrowth in PC12 cells through p38 MAPK signaling
af: Moriyama Mariko, et al.
Udgivet: (2012-08-01)