Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol
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 a...
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BMJ Publishing Group
2021-08-01
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| author | Joan Montaner Francisco Moniche Alberto M Borobia Blanca Fuentes Exuperio Diez-Tejedor Elena de Celis-Ruiz Maria Gutiérrez-Fernández |
| author_facet | Joan Montaner Francisco Moniche Alberto M Borobia Blanca Fuentes Exuperio Diez-Tejedor Elena de Celis-Ruiz Maria Gutiérrez-Fernández |
| author_sort | Joan Montaner |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-f6c7cf8590ab4f599d5ea11f39d4bccd |
| institution | OA Journals |
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| language | English |
| publishDate | 2021-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-f6c7cf8590ab4f599d5ea11f39d4bccd2025-08-20T02:20:57ZengBMJ Publishing GroupBMJ Open2044-60552021-08-0111810.1136/bmjopen-2021-051790Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocolJoan Montaner0Francisco Moniche1Alberto M Borobia2Blanca Fuentes3Exuperio Diez-Tejedor4Elena de Celis-Ruiz5Maria Gutiérrez-Fernández6Neurovascular Research Laboratory, Vall d’Hebron Research Institute, Vall d’Hebron Hospital, Autonomous University of Barcelona, Barcelona, SpainStroke Unit, Department of Neurology, Virgen del Rocio University Hospital, Sevilla, SpainDepartment of Clinical Pharmacology, Hospital La Paz Institute for Health Research-IdiPAZ (La Paz University Hospital-Universidad Autónoma de Madrid), Madrid, SpainDepartment of Neurology, Hospital La Paz Institute for Health Research-IdiPAZ (La Paz University Hospital-Universidad Autónoma de Madrid), Madrid, SpainDepartment of Neurology, Hospital La Paz Institute for Health Research-IdiPAZ (La Paz University Hospital-Universidad Autónoma de Madrid), Madrid, Spain1 Department of Neurology and Stroke Centre, La Paz University Hospital and Department of Medicine, Universidad Autónoma de Madrid, La Paz University Hospital Research Institute (IdiPAZ), Madrid, Spain3 Neurological Sciences and Cerebrovascular Research Laboratory, La Paz University Hospital Research Institute (IdiPAZ), Madrid, SpainIntroduction 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.https://bmjopen.bmj.com/content/11/8/e051790.full |
| spellingShingle | Joan Montaner Francisco Moniche Alberto M Borobia Blanca Fuentes Exuperio Diez-Tejedor Elena de Celis-Ruiz Maria Gutiérrez-Fernández Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol BMJ Open |
| title | Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol |
| title_full | Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol |
| title_fullStr | Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol |
| title_full_unstemmed | Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol |
| title_short | Allogeneic adipose tissue-derived mesenchymal stem cells in ischaemic stroke (AMASCIS-02): a phase IIb, multicentre, double-blind, placebo-controlled clinical trial protocol |
| title_sort | allogeneic adipose tissue derived mesenchymal stem cells in ischaemic stroke amascis 02 a phase iib multicentre double blind placebo controlled clinical trial protocol |
| url | https://bmjopen.bmj.com/content/11/8/e051790.full |
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