Safety of allogenic mesenchymal stem cells derived exosome on disability of patients with acute ischaemic stroke: a randomised, open labled, placebo-controlled, phase 1 trial
Safety assessment of allogenic mesenchymal stem cells derived exosome injection in patients with acute ischemic stroke
Design
Study Phase: Phase 1/Phase 2 Interventional Study Model: Single Group Assignment Number of Arms: 1 Masking: None (Open Label) Allocation: N/A Enrollment: 5
Settings and conduct
Tajrish Shohada Hospital, Tehran, Iran
Participants/Inclusion and exclusion 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 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 • 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 hemorrhage.
• 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.
Intervention groups
Exosome Injection in patients with acute ischemic stroke
Main outcome variables
Safety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141224020427N4
Registration date:2020-11-11, 1399/08/21
Registration timing:registered_while_recruiting
Last update:2020-11-11, 1399/08/21
Update count:0
Registration date
2020-11-11, 1399/08/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 1250
Email address
leiladehghani@azh.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-09, 1399/08/19
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety of allogenic mesenchymal stem cells derived exosome on disability of patients with acute ischaemic stroke: a randomised, open labled, placebo-controlled, phase 1 trial
Public title
Exosome Therapy in Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male acute ischemic patients aged 40-80 years with symptoms of acute cerebral infarction of less than 24h from stroke onset.
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,
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.
Age
From 40 years old to 80 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
5
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
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT03384433
Registration date
2019-07-20, 1398/04/29
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.SBMU.REC.1398.062
Health conditions studied
1
Description of health condition studied
Ischemic Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Fever
Timepoint
3, 30 and 90 days after injection
Method of measurement
Thermometer
2
Description
high sensitivity C-Reactive protein
Timepoint
3, 30, 90 days after injection
Method of measurement
Colorimetric Method
3
Description
Recurrent Stroke
Timepoint
3, 30, 90 days after injection
Method of measurement
computerized tomography (CT)
4
Description
hemorrhagic transformation
Timepoint
3, 30, 90 days after injection
Method of measurement
computerized tomography (CT)
5
Description
Brain Oedema
Timepoint
3, 30 , 90 days after injection
Method of measurement
computerized tomography (CT)
Secondary outcomes
empty
Intervention groups
1
Description
Allogenic Mesenchymal stem cell derived Exosome injection locally in ischemic region under decompress surgery in patient with acute ischemic stroke. The exosome concentration is 200Mg/ml and patients receive one dose for one time
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tajrish hospital
Full name of responsible person
Masoud Soleimani
Street address
Tajrish Squ
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arash Khojasteh
Street address
Arabi St, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@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
Saeed Oraee Yazdani
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Tajrish Hospital, tajrish squ
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
saeed_o_yazdani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoud Soleimani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Velenjak, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9847
Email
soleimani.masoud@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Dehghani
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Velenjak, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9847
Email
l_dehghani2002@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles
When the data will become available and for how long
The non-identifiable individual participant data will become available after the publication of the relevant articles
To whom data/document is available
The non-identifiable individual participant data will become available to other researchers in academic institutions
Under which criteria data/document could be used
The non-identifiable individual participant data can only be used for research
From where data/document is obtainable
The non-identifiable individual participant data will be obtainable by sending an e-mail to Prof.Masoud Soleimani (Email: Soleimani.masoud@gamil.com)
What processes are involved for a request to access data/document
Other researchers in academic institutions can send their request by e-mail to Prof.Masoud Soleimani (Email: Soleimani.masoud@gamil.com). The data will be sent to them after consulting and approving the research team