Status:
UNKNOWN
Allogenic Mesenchymal Stem Cell Derived Exosome in Patients With Acute Ischemic Stroke
Lead Sponsor:
Isfahan University of Medical Sciences
Collaborating Sponsors:
Tarbiat Modarres University
Conditions:
Cerebrovascular Disorders
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
PHASE2
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 admin...
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 increas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 17 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03384433
Start Date
April 17 2019
End Date
December 17 2021
Last Update
January 25 2021
Active Locations (1)
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1
Shahid Beheshti University of Medical Sciences
Tehran, Iran