Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): A phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol
Entidad
UAM. Departamento de Farmacología; UAM. Departamento de MedicinaEditor
Bmj Publishing GroupFecha de edición
2021-08-09Cita
10.1136/bmjopen-2021-051790
Bmj Open 11.8 (2021): e051790
ISSN
2044-6055DOI
10.1136/bmjopen-2021-051790Financiado por
This clinical trial has been promoted by the La Paz University Hospital Institute for Health Research—IdiPAZ (La Paz University Hospital—Universidad Autónoma de Madrid) and sponsored from a competitive grant from the Carlos III Health Institute Healthcare Research Fund, and cofunded by the European Regional Development Fund (ERDF) 'A way to make Europe'/'Investing in your future' (PIC18/00016). This clinical trial has been supported by Plataforma Española de Investigación Clínica y Ensayos Clínicos, SCReN (Spanish Clinical Research Network), funded by Carlos III Health Institute-General Subdirection for Evaluation and Promotion of Research, research PT17/0017/0013; State Plan for Scientific Investigation, Technology and Innovation (2017–2020) and cofunded by European Regional Development Fund/European Social fund 'A way to make Europe'/'Investing in your future' (grant ID PT17/0017/0013)Proyecto
Gobierno de España. PIC18/00016; info:eu-repo/grantAgreement/EC/ERDF/PT17/0017/0013Versión del editor
https://doi.org/10.1136/bmjopen-2021-051790Materias
adverse events; clinical trials; stroke; therapy; metaanalysis; strategy; safety; MedicinaDerechos
© Author(s) (or their employer(s)) 2021Resumen
Introduction Stroke is a serious public health problem, given it is a major cause of disability worldwide despite the spread of recanalisation therapies. Enhancement of brain plasticity with stem cell administration is a promising innovative therapy to reduce sequelae in these patients. Methods and analysis We have developed a phase IIb, multicentre, randomised, double-blind, placebo-controlled clinical trial protocol to evaluate the safety and efficacy of intravenous administration of allogeneic adipose tissue-derived mesenchymal stem cells (AD-MSCs) in patients with acute ischaemic stroke, concurrently with conventional stroke treatment. Thirty patients will be randomised on a 1:1 basis to receive either intravenous placebo or allogeneic AD-MSCs as soon as possible within the first 4 days from stroke symptom onset. Patients will be followed up to 24 months after randomisation. The primary objective is the safety assessment of early intravenous administration of allogeneic AD-MSCs by reporting all adverse events and neurological or systemic complications in both treatment groups. Secondary objectives assess efficacy of early intravenous AD-MSC treatment in acute ischaemic stroke by evaluating changes in the modified Rankin Scale and the National Institutes of Health Stroke Scale throughout the follow-up period. In addition, brain repair biomarkers will be measured at various visits. Ethics and dissemination This clinical trial has been approved by the Clinical Research Ethics Committee of La Paz University Hospital (Madrid, Spain) and by the Spanish Agency of Medication and Health Products and has been registered in Eudra CT (2019-001724-35) and ClinicalTrials.gov (NCT04280003). Study results will be disseminated through peer-reviewed publications in Open Access format and at conference presentations
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Google Scholar:De Celis-Ruiz, Elena
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Fuentes Gimeno, Blanca Eulalia
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Moniche, Francisco
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Montaner, Joan
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Borobia Pérez, Alberto M.
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Gutiérrez-Fernández, Maria
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Díez Tejedor, Exuperio
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