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Safety and feasibility of systemic intravenous infusion of mesenchymal stem cell-derived exosomes in patients with acute ischemic stroke

Protocol summary

Study aim
This study aims to evaluate the safety and feasibility of intravenous systemic infusion of mesenchymal stem cell-derived exosomes in patients with acute ischemic stroke.
Design
This investigation is a single-arm, open-label, non-randomized, phase I clinical trial, including 9 patients with acute ischemic stroke.
Settings and conduct
Since this study aims to evaluate the safety of exosome therapy, no blinding will be performed. A total of 9 patients will be assigned to the single study intervention arm and will receive intravenous infusion of exosomes as the study intervention.
Participants/Inclusion and exclusion criteria
Patients with age between 18 and 80, diagnosis of acute ischemic stroke based on clinical and radiological evidence, time from onset to injection of 24 to 72 h, and National Institutes of Health Stroke Scale (NIHSS) between 6 and 20 will be included in this study. Patients with lacunar or brainstem stroke, acute intracranial hemorrhage, history of seizure, current or prior traumatic brain injury, history of ischemic stroke or myocardial infarction within the last 6 months, and abnormal renal, hepatic, immunologic, and coagulation profiles will be excluded from the study.
Intervention groups
All patients will be assigned to the single study intervention arm. Patients in the intervention arm will receive the systemic intravenous infusion of mesenchymal stem cell-derived exosomes.
Main outcome variables
The primary outcome measure of the study will be safety profile of the study intervention. Secondary outcome measures will be National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200502047277N9
Registration date: 2022-09-17, 1401/06/26
Registration timing: prospective

Last update: 2022-09-17, 1401/06/26
Update count: 0
Registration date
2022-09-17, 1401/06/26
Registrant information
Name
saeed oraee yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 25719
Email address
saeed_o_yazdani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and feasibility of systemic intravenous infusion of mesenchymal stem cell-derived exosomes in patients with acute ischemic stroke
Public title
Exosome in acute ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 80 years Diagnosis of acute ischemic stroke based on clinical and imaging evidence within 24 to 72 h after the onset Baseline National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20
Exclusion criteria:
Diagnosis of lacunar or brainstem stroke Acute intracranial hemorrhage History of seizure or current therapy with anti-epileptic medications Any history of traumatic brain injury Any uncontrolled comorbidity, such as diabetes, hepatic, renal, or cardiac failure Ischemic stroke or myocardial infarction within the last 6 months Abnormal renal, hepatic, immunologic, and coagulation profiles Pregnancy and lactation
Age
From 18 years old to 80 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 9
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences ,Shahid Arabi St., Yemen St., Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-06-12, 1401/03/22
Ethics committee reference number
IR.SBMU.REC.1401.009

Health conditions studied

1

Description of health condition studied
Cerebral infarction
ICD-10 code
I63
ICD-10 code description
Cerebral infarction

Primary outcomes

1

Description
Safety profile of the study intervention
Timepoint
Daily during the first 7 days after the injection and weekly until 3-month after the injection
Method of measurement
Monitoring and evaluating the patients regarding the adverse events

Secondary outcomes

1

Description
National Institutes of Health Stroke Scale (NIHSS)
Timepoint
1-, 3-, and 6-month after the injection
Method of measurement
Physical examination

2

Description
Modified Rankin scale (mRS)
Timepoint
1-, 3-, and 6-month after the injection
Method of measurement
Evaluation of patient

Intervention groups

1

Description
Intervention group: All patients (n=9) will be assigned to the single study intervention group. The process of exosome isolation and preparation will be performed in a clinical-grade cleanroom and in complicance with Good Manufacturing Practices (cGMP). Patients will receive 500 μg of exosomes in 100 mL of normal saline as a single intravenous infusion over 30 min. The exosomes will be injected within 24 to 72 h after the onset. Following the injection, all patients will undergo standard care for acute stroke.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Saeed Oraee Yazdani
Street address
Shohadaye Tajrish Hospital, Tajrish Square, Tehran.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Saeed_o_yazdani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Building Number.2, Shahid Beheshti University of Medical Sciences, Arabi Avenue, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roozbeh Tavanaei
Position
Research associate
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2270 1022
Email
rtavanaei@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Oraee Yazdani
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Shohadaye Tajrish Hospital, Tajrish Ave.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
saeed_o_yazdani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roozbeh Tavanaei
Position
Research associate
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Functional Neurosurgery Research Center (FNRC), SBMU Shohada-E-Tajrish Educational Hospital, Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2270 1022
Email
rtavanaei@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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