Safety and Efficacy of Allogenic Mesenchymal Stem Cells Derived Exosome on Disability of Patients With Acute Ischemic Stroke: a Randomized, Single-blind, Placebo-controlled, Phase 1, 2 Trial
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
Study Overview
Brief Summary
Administration of cell-free exosomes derived from mesenchymal stem cell (MSCs) can be sufficient to exert therapeutic effects of intact MSCs after brain injury. In this study we aim to assay the administration of MSC derived exosome on improvement of disability of patients with acute ischemic stroke
Detailed Description
Exosomes derived from multipotent mesenchymal stromal cells (MSCs) promote neurovascular remodeling and functional recovery after stroke. Animal study has shown that Exosome treatment markedly increased the number of newly formed doublecortin (a marker of neuroblasts) and von Willebrand factor (a marker of endothelial cells) cells. Based on previous literature, intravenous administration of MSC-generated exosomes post stroke improves functional recovery and enhances neurite remodeling, neurogenesis, and angiogenesis and represents a novel treatment for stroke. Also some studies have presented which miR-124-Loaded Exosomes ameliorate the brain Injury by promoting neurogenesis. So in present study we aim to assess improving patients with acute ischemic stroke who received MSC derived exosome
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female acute ischemic patients aged 40-80 years with symptoms of acute cerebral infarction of less than 24h from stroke onset.
- •Patients with infarct size 3*3
- •Patients with a measurable focal neurological that must persist to the time of treatment without clinically meaningful improvement.
- •Patients must have computerized tomography (CT) and / or magnetic resonance imaging (MRI) compatible with the clinical diagnosis of acute ischemic stroke in the territory of the middle cerebral artery before being included in the study.
- •Patients must have a score on the NIH Stroke Scale 8-24, and mRS ≤ 1
- •Women of childbearing age should have a negative pregnancy test performed prior to inclusion
- •Obtaining informed consent signed
Exclusion Criteria
- •Comatose patients.
- •brain tumour, cerebral oedema with compression of ventricles, cerebellar infarction or brainstem, or intraventricular, intracerebral or subarachnoid haemorrhage.
- •alcohol use Active infectious disease, including HIV, hepatitis B, Hepatitis .
- •patients with dementia.
- •Specify clinical conditions
- •Patients who are participating in another clinical trial.
- •Inability or unwillingness of individual for giving written informed consent.
Arms & Interventions
exosome or vesicle
CVA patients who have disability, will receive total protein of allogenic MSC-generated exosome transfected by miR-124, one month after attack, via Stereotaxis/Intraparanchymal
Intervention: exosome (Biological)
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events
Time Frame: 12 months
deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation
Secondary Outcomes
- measurement of Modified Ranking Scale(12 months)
Investigators
Leila Dehghani
Dr Masoud Soleimani
Isfahan University of Medical Sciences