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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03384433
Recruitment Status : Unknown
Verified January 2021 by Leila Dehghani, Isfahan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 27, 2017
Last Update Posted : January 25, 2021
Sponsor:
Collaborator:
Tarbiat Modarres University
Information provided by (Responsible Party):
Leila Dehghani, Isfahan University of Medical Sciences

Study Description
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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

Condition or disease Intervention/treatment Phase
Cerebrovascular Disorders Biological: exosome Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : June 17, 2021
Estimated Study Completion Date : December 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Biological: exosome
allogenic mesenchymal stem cells derived exosome enriched by miR-124


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 12 months ]
    deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation


Secondary Outcome Measures :
  1. measurement of Modified Ranking Scale [ Time Frame: 12 months ]

    measure the degree of disability in Stroke patients. score was recorded from 0-6.

    0 No symptoms at all

    1. No significant disability despite symptoms; able to carry out all usual duties and activities
    2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
    3. Moderate disability; requiring some help, but able to walk without assistance
    4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
    5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
    6. Dead


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384433


Contacts
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Contact: Masoud Soleimani, Prof 09122875993 soleim_m@modares.ac.ir
Contact: Leila Dehghani, Assis 09131363593 l_dehghani2002@yahoo.com

Locations
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Iran, Islamic Republic of
Shahid Beheshti University of Medical Sciences Recruiting
Tehran, Iran, Islamic Republic of
Contact: Leila Dehghani, Dr         
Sponsors and Collaborators
Isfahan University of Medical Sciences
Tarbiat Modarres University
Investigators
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Study Director: Saeed Oraee-Yazdani, Dr Shahid Beheshti University of Medical Sciences
More Information
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Responsible Party: Leila Dehghani, Dr Masoud Soleimani, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03384433    
Other Study ID Numbers: med shahid beheshti university
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ischemic Stroke
Cerebrovascular Disorders
Stroke
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases