Cerebrovascular DisordersPhase 1/2NCT03384433
Allogenic Mesenchymal Stem Cell Derived Exosome in Patients With Acute Ischemic Stroke
A Phase 1/2 study testing exosome in people with Cerebrovascular Disorders, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cerebrovascular Disorders
- What is being tested?
- exosome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIran
- Study dates
- 17 Apr 2019to 17 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid Beheshti University of Medical Sciences
Tehran
Leila Dehghani, Dr
About this study
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
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
Read the 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
- Conditions
- Cerebrovascular Disorders
- Being tested
- exosome
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exosomeBiological
allogenic mesenchymal stem cells derived exosome enriched by miR-124
| Study group | Role | What they receive |
|---|---|---|
| exosome or vesicle | Experimental | 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 Receives: Biological: exosome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start17 Apr 2019
- Primary completion17 Jun 2021 (estimated)
- Study completion17 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tarbiat Modarres University
- Responsible party
- Principal investigator, Leila Dehghani, Isfahan University of Medical Sciences
- Investigators
- Saeed Oraee-Yazdani, Dr, Study director, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384433
- Sponsor's protocol ID
- med shahid beheshti university
- Status last verified
- Jan 2021
- First submitted
- 29 Nov 2017
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aldali F, Deng C, Nie M, Chen H. Advances in therapies using mesenchymal stem cells and their exosomes for treatment of peripheral nerve injury: state of the art and future perspectives. Neural Regen Res. 2025 Nov 1;20(11):3151-3171. doi: 10.4103/NRR.NRR-D-24-00235. Epub 2024 Oct 22.
PubMed 39435603
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03384433
- Acronym / sponsor ID
- med shahid beheshti university
- Conditions
- Cerebrovascular Disorders
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Tarbiat Modarres University
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 17 Jun 2021 (estimated)
- Study completion
- 17 Dec 2021 (estimated)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exosome or vesicle | Experimental | Biological: exosomeCVA patients who have disability, will receive total protein of allogenic MSC-generated exosome transfected by miR-124, one month after attack, via Stereotaxis/Intraparanchymal |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exosomeallogenic mesenchymal stem cells derived exosome enriched by miR-124 | Biological | exosome or vesicle |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 12 months
deteriorating stroke, stroke recurrences, brain oedema, seizures, hemorrhagic transformation
1 secondary outcome
measurement of Modified Ranking Scale
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Derived from this study: PubMed 39435603Aldali F, Deng C, Nie M, Chen H. Advances in therapies using mesenchymal stem cells and their exosomes for treatment of peripheral nerve injury: state of the art and future perspectives. Neural Regen Res. 2025 Nov 1;20(11):3151-3171. doi: 10.4103/NRR.NRR-D-24-00235. Epub 2024 Oct 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saeed Oraee-Yazdani, Dr study director
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing exosome in people with Cerebrovascular Disorders, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Masoud Soleimani, Prof (09122875993, soleim_m@modares.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03384433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.