This is a multicenter, doble blind, placebo controlled clinical trial to asses de safety and efficacy of intravenous administration of alogenic adipose tissue-derived mesenchymal stem cells in the first four days from acute ischemic stroke.
Two spanish hospitals with teams experienced in stroke management will participate in this study, recruiting a total of 30 patients between them both. After confirming that patients fulfill the inclusion criteria and none of the exclusion criteria, informed consent will be signed and randomization will take place (1:1). There are two different groups of treatment; the first group will be treated with intravenous alogenic adipose tissue-derived stem cells (at a concentration of one million cells per kg) within the first four days from stroke onset, the second group will be treated will an intravenous placebo solution. Follow-up will last for 24 months during which safety issues such as adverse events and neurological and systemic complications will be assessed at 24 hours, 7 days and 3, 6, 12,18 and 24 months after treatment. Neurological disability using the modified Rankin Scale and National Institute of Health Stroke Scale will also be registered in every scheduled visit. Biochemical markers of tissue repair (GM-CSF, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3) as well as extracellular vesicles will be extracted on baseline visit as well as 7 days and 3 months after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Concentration of the cells: 10 million cells / ml
Placebo intravenous solution, same appearance stem cells solution
Hospital Universitario La Paz
Madrid, Spain
RECRUITINGSafety of administration of adipose tissue-derived mesenchymal stem cells measured as reported adverse events
Adverse events reported spontaneously or in response to questions not addressed.
Time frame: Up to 24 months after treatment or placebo administration
Safety of administration of adipose tissue-derived mesenchymal stem cells measured as neurological o systemic complications
Neurological or systemic complications
Time frame: Up to 24 months after treatment or placebo administration
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the Modified Rankin Scale
Modified Rankin Scale (mRS): success is considered when the patient obtains a score of 0-3, and failure include scores of 4 to 6 at months 3,6,12 and 24. An additional exploratorry efficacy analysis of mRS shift at months 3,6,12 and 24 will also be made.
Time frame: Up to 24 months after treatment or placebo administration
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measured by the NIHSS
National Institute of Health Stroke Scale. It will be measured at all scheluded visits. Success is defined as an improvement of 75% or more from baseline. An additional exploratory analysis will look for differences in the distribution of median (IQR) and in the frequency of NIHSS ≤ 1between groups.
Time frame: Up to 24 months after treatment or placebo administration
Efficacy of administration of adipose tissue-derived mesenchymal stem cells measuring blood brain repair biomarkers
Brain repair biomarkers in blood samples (GM-CSF, PDGF-BB, BDNF, VEGF, TGF-1, GFAP, MBP, MMP-3 and extracelular vesicles) measured at baseline, day 7 and mnth 3 after treatment or placebo administration.
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Time frame: Up to 3 months after treatment or placebo administration