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

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ClinicalTrials.gov Identifier: NCT03384433
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE November 29, 2017
First Posted Date  ICMJE December 27, 2017
Last Update Posted Date January 25, 2021
Actual Study Start Date  ICMJE April 17, 2019
Estimated Primary Completion Date June 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 25, 2017)
Incidence of Treatment-Emergent Adverse Events [ Time Frame: 12 months ]
deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2017)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 25, 2017)
measurement of Modified Ranking Scale (MRS) [ Time Frame: 12 months ]
measure the degree of disability in Stroke patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogenic Mesenchymal Stem Cell Derived Exosome in Patients With Acute Ischemic Stroke
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebrovascular Disorders
Intervention  ICMJE Biological: exosome
allogenic mesenchymal stem cells derived exosome enriched by miR-124
Study Arms  ICMJE 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
Intervention: Biological: exosome
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 25, 2017)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 17, 2021
Estimated Primary Completion Date June 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Masoud Soleimani, Prof 09122875993 soleim_m@modares.ac.ir
Contact: Leila Dehghani, Assis 09131363593 l_dehghani2002@yahoo.com
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03384433
Other Study ID Numbers  ICMJE med shahid beheshti university
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Leila Dehghani, Isfahan University of Medical Sciences
Study Sponsor  ICMJE Isfahan University of Medical Sciences
Collaborators  ICMJE Tarbiat Modarres University
Investigators  ICMJE
Study Director: Saeed Oraee-Yazdani, Dr Shahid Beheshti University of Medical Sciences
PRS Account Isfahan University of Medical Sciences
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP