Allogenic Mesenchymal Stem Cell Derived Exosome in Patients With Acute Ischemic Stroke
Primary Purpose
Cerebrovascular Disorders
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
exosome
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Disorders
Eligibility 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.
Sites / Locations
- Shahid Beheshti University of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exosome or vesicle
Arm 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
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation
Secondary Outcome Measures
measurement of Modified Ranking Scale
measure the degree of disability in Stroke patients. score was recorded from 0-6.
0 No symptoms at all
No significant disability despite symptoms; able to carry out all usual duties and activities
Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
Moderate disability; requiring some help, but able to walk without assistance
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
Severe disability; bedridden, incontinent and requiring constant nursing care and attention
Dead
Full Information
NCT ID
NCT03384433
First Posted
November 29, 2017
Last Updated
January 21, 2021
Sponsor
Isfahan University of Medical Sciences
Collaborators
Tarbiat Modarres University
1. Study Identification
Unique Protocol Identification Number
NCT03384433
Brief Title
Allogenic Mesenchymal Stem Cell Derived Exosome in Patients With Acute Ischemic Stroke
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
June 17, 2021 (Anticipated)
Study Completion Date
December 17, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
Collaborators
Tarbiat Modarres University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exosome or vesicle
Arm Type
Experimental
Arm 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
Intervention Type
Biological
Intervention Name(s)
exosome
Intervention Description
allogenic mesenchymal stem cells derived exosome enriched by miR-124
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
measurement of Modified Ranking Scale
Description
measure the degree of disability in Stroke patients. score was recorded from 0-6.
0 No symptoms at all
No significant disability despite symptoms; able to carry out all usual duties and activities
Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
Moderate disability; requiring some help, but able to walk without assistance
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
Severe disability; bedridden, incontinent and requiring constant nursing care and attention
Dead
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masoud Soleimani, Prof
Phone
09122875993
Email
soleim_m@modares.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Leila Dehghani, Assis
Phone
09131363593
Email
l_dehghani2002@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saeed Oraee-Yazdani, Dr
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Shahid Beheshti University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leila Dehghani, Dr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Allogenic Mesenchymal Stem Cell Derived Exosome in Patients With Acute Ischemic Stroke
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