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...

Descrizione completa

Dettagli Bibliografici
Autori principali:	Akihiro Hirakawa, Masahiko Ando, Masahiro Hayakawa, Nao Matsuyama, Shinobu Shimizu, Kazuto Ueda, Toshihiko Suzuki, Sakiko Suzuki, Ryosuke Miura, Akemi Katayama, Masaaki Mizuno, Yoshiaki Sato
Natura:	Articolo
Lingua:	English
Pubblicazione:	BMJ Publishing Group 2022-04-01
Serie:	BMJ Open
Accesso online:	https://bmjopen.bmj.com/content/12/4/e057073.full

Documenti analoghi

Systemic administration of clinical-grade multilineage-differentiating stress-enduring cells ameliorates hypoxic–ischemic brain injury in neonatal rats
di: Kazuto Ueda, et al.
Pubblicazione: (2023-09-01)

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

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

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

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

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

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

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

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

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

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

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

Decreasing Hypothermia-Related Escalation of Care in Newborn Infants Using the BEMPU TempWatch: A Randomised Controlled Trial
di: Donna Lei, et al.
Pubblicazione: (2021-11-01)

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

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

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

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

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

Embedding the ‘CoolCuddle’ intervention for infants undergoing therapeutic hypothermia for hypoxic-ischaemic encephalopathy in NICU: an evaluation using normalisation process theory
di: Lucy Beasant, et al.
Pubblicazione: (2024-10-01)

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

Why hypothermia in neonatal hypoxic ischemic encephalopathy?
di: K Gücüyener, et al.
Pubblicazione: (2001-01-01)

Therapeutic hypothermia for neonates with hypoxic ischemic encephalopathy
di: Ming-Chou Chiang, et al.
Pubblicazione: (2017-12-01)

Hypothermia therapy for newborns with hypoxic ischemic encephalopathy
di: Rita C. Silveira, et al.
Pubblicazione: (2015-11-01)

Hypothermia therapy for newborns with hypoxic ischemic encephalopathy
di: Rita C. Silveira, et al.
Pubblicazione: (2015-11-01)

Evidence and opportunities of hypothermia in acute ischemic stroke: Clinical trials of systemic versus selective hypothermia
di: Christian Huber, et al.
Pubblicazione: (2019-01-01)

Administration of Bone Marrow-Derived Mononuclear Cells Contributed to the Reduction of Hypoxic-Ischemic Brain Injury in Neonatal Rats
di: Yoshiaki Sato, et al.
Pubblicazione: (2018-11-01)

Epidemiology of neonatal encephalopathy and hypoxic-ischaemic encephalopathy.
di: Kurinczuk, J, et al.
Pubblicazione: (2010)

Hypoxic Ischaemic Injury in an Immature Brain on MRI
di: Niketa Chotai MD (India), FRCR (UK), et al.
Pubblicazione: (2010-06-01)

Combined therapy in neonatal hypoxic-ischaemic encephalopathy
di: María Cánovas-Ahedo, et al.
Pubblicazione: (2019-07-01)

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

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

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

Adherence to hypothermia guidelines in newborns with hypoxic-ischemic encephalopathy
di: Cristina Vega-del-Val, et al.
Pubblicazione: (2022-07-01)

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

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

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

Developmental amnesia associated with early hypoxic-ischaemic injury.
di: Gadian, D, et al.
Pubblicazione: (2000)

Rationale for the Use of Cord Blood in Hypoxic-Ischaemic Encephalopathy
di: Izabela Zdolińska-Malinowska, et al.
Pubblicazione: (2022-01-01)

Plasticity in the Neonatal Brain following Hypoxic-Ischaemic Injury
di: Eridan Rocha-Ferreira, et al.
Pubblicazione: (2016-01-01)

Severity of Hypoxic Ischaemic Encephalopathy in Neonates with Birth Asphyxia
di: Rubina Zulfiqar
Pubblicazione: (2007-06-01)