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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cerebrovascular Disorders
• Intervention / Treatment: Biological: exosome

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: Interventional
• Enrollment (Anticipated): 5
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Masoud Soleimani, Prof; Phone Number: 09122875993; Email: soleim_m@modares.ac.ir
• Study Contact Backup: Name: Leila Dehghani, Assis; Phone Number: 09131363593; Email: l_dehghani2002@yahoo.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Shahid Beheshti University of Medical Sciences
    • Contact: Leila Dehghani, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Collaborators: Tarbiat Modarres University
• Investigators: Study Director: Saeed Oraee-Yazdani, Dr, Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Anticipated): June 17, 2021
• Study Completion (Anticipated): December 17, 2021

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 25, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Cerebrovascular Disorders
• Other Study ID Numbers: med shahid beheshti university

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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