Allogenic Mesenchymal Stem Cell Derived Exosome in Patients With Acute Ischemic Stroke

Isfahan University of Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cerebrovascular Disorders

Treatments: Biological: exosome

Study type: Interventional

Funder types: Other

Identifiers

NCT03384433

med shahid beheshti university

Details and patient eligibility

About

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

Full 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

Enrollment: 5 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

exosome or vesicle

Experimental group

Description:

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

Treatment:

Biological: exosome