Short-Term Safety of Allogeneic Adipose-Tissue Derived Mesenchymal Stem Cells in Acute Ischemic Stroke (AMASCIS): A Phase II, Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Pilot Clinical Trial

2019 ◽  
Author(s):  
Blanca Fuentes ◽  
Raquel Gutiérrez-Zúñiga ◽  
María Gutiérrez-Fernández ◽  
María Alonso de Leciñana ◽  
Alberto M. Borobia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Adipose Tissue ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Single Centre ◽  
Short Term ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals 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 ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e051790
Author(s):  
Elena de Celis-Ruiz ◽  
Blanca Fuentes ◽  
Francisco Moniche ◽  
Joan Montaner ◽  
Alberto M Borobia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Adipose Tissue ◽  
Ischaemic Stroke ◽  
Acute Ischaemic Stroke ◽  
Controlled Clinical Trial ◽  
Trial Protocol ◽  
Double Blind ◽  
Double Blind Placebo

IntroductionStroke 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 analysisWe 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 disseminationThis 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.

scholarly journals Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2017 ◽  
Vol 72 (11) ◽  
pp. 1513-1522 ◽  
Author(s):  
Bryon A Tompkins ◽  
Darcy L DiFede ◽  
Aisha Khan ◽  
Ana Marie Landin ◽  
Ivonne Hernandez Schulman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Phase Ii ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Double Blind Placebo

Reparative Therapy for Acute Ischemic Stroke with Allogeneic Mesenchymal Stem Cells from Adipose Tissue: A Safety Assessment

2014 ◽  
Vol 23 (10) ◽  
pp. 2694-2700 ◽  
Author(s):  
Exuperio Díez-Tejedor ◽  
María Gutiérrez-Fernández ◽  
Patricia Martínez-Sánchez ◽  
Berta Rodríguez-Frutos ◽  
Gerardo Ruiz-Ares ◽  
...  
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Adipose Tissue ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Safety Assessment ◽  
Reparative Therapy

scholarly journals Mesenchymal Stem Cells Overexpressing Interleukin-10 Promote Neuroprotection in Experimental Acute Ischemic Stroke

2017 ◽  
Vol 6 ◽  
pp. 102-111 ◽  
Author(s):  
Masataka Nakajima ◽  
Chikako Nito ◽  
Kota Sowa ◽  
Satoshi Suda ◽  
Yasuhiro Nishiyama ◽  
...  
Keyword(s):  
Stem Cells ◽  
Mesenchymal Stem Cells ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Interleukin 10
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