Cognitive ImpairmentPhase 1/2NCT07145294
Induced Pluripotent Stem Cells-derived Small Extracellular Vesicles May Promote Neurological Function and Improve Cognitive Impairment in Acute Ischemic Stroke Patients
A Phase 1/2 study testing iEV and Basic treatments in people with Cognitive Impairment, run by Hongmei Wang at 1 site in China.
Trial summary
This study primarily evaluates whether iEV nasal administration can improve neurological impairment and cognitive dysfunction in patients with acute cerebral infarction and cognitive impairment, and preliminarily explores its clinical efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- iEV and Basic treatments
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2025to 1 Jan 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Diagnosed with acute ischemic stroke (AIS) according to WHO criteria.
- Time from onset to enrollment ≤ 2 weeks (stable condition after admission and able to cooperate with cognitive assessment), accompanied by manifestations of cognitive impairment, with a score of < 26 on the Montreal Cognitive Assessment (MoCA) scale.
- Cerebral MRI or CT scan shows stroke lesions related to the condition.
- Subjects or their family members voluntarily participate and sign the informed consent form.
Who cannot join
- A diagnosis of cognitive impairment prior to the onset of AIS;
- Presence of aphasia, hearing impairment, visual impairment, dysarthria, or other conditions that prevent completion of neuropsychological assessments;
- Patients with mental illnesses such as depression, anxiety disorder, or schizophrenia;
- Patients with severe diseases of the heart, liver, lungs, kidneys, or other vital organs;
- Patients with disturbed consciousness, a history of long-term alcohol consumption, a history of severe head trauma, or those who cannot cooperate with cognitive function tests for various reasons;
- illiterate patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, 200000
Shankai Yin, +862164369181, liuyuanec@163.com
liuyuanec@163.com
About this study
This study primarily evaluates whether iEV nasal administration can improve neurological impairment and cognitive dysfunction in patients with acute cerebral infarction and cognitive impairment, and preliminarily explores its clinical efficacy.
Read the detailed description
- It is planned to enroll 40 patients with post - stroke cognitive impairment (PSCI, i.e., acute ischemic stroke (AIS) combined with cognitive impairment) who are hospitalized in the Department of Neurology and Stroke Ward of Shanghai Sixth People's Hospital. These patients should have had an AIS onset within 14 days. They will be divided into the PSCI + treatment group and the PSCI + control group according to a random number table, with 20 patients in each group.
- Enrolled patients need to first complete blood tests such as blood routine and blood biochemistry, as well as skull MRI or skull CT examinations. The total course of treatment for both groups will be 12 weeks.
- Both the treatment group and the control group will receive conventional basic treatment for cerebrovascular diseases. In addition, the treatment group will be given intranasal iEV administration, twice a week, 2 ml each time (with a concentration of 2×10¹⁰/ml), for 12 consecutive weeks. Before treatment and 12 weeks after treatment, the severity of neurological impairment, self - care ability, disability status, and cognitive function status will be evaluated to assess the therapeutic effect of iEV on neurological impairment and cognitive dysfunction in PSCI patients.
- Before intranasal iEV treatment and 12 weeks after treatment, blood samples will be collected respectively to detect changes in indicators such as nerve cell damage, pro - inflammatory factors, angiogenesis, and blood - brain barrier disruption, so as to clarify the neuroprotective mechanism of iEV in PSCI patients.
- Conditions
- Cognitive Impairment
- Being tested
- iEV, Basic treatments
- Keywords
- Neuronal damage and cognitive dysfunction induced by acute cerebral ischemia
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iEVBiological
Intranasal administration of iEV, twice a week, 2 ml each time (at a concentration of 2×10¹⁰/ml), for 12 consecutive weeks.
Basic treatmentsOther
Basic treatments for cerebrovascular diseases such as antiplatelet aggregation, blood pressure control, blood glucose control, blood lipid control, and plaque stabilization.
| Study group | Role | What they receive |
|---|---|---|
| PSCI+iEV | Experimental | Intranasal administration of iEV, twice a week, 2 ml each time (at a concentration of 2×10¹⁰/ml), for 12 consecutive weeks. Receives: Biological: iEV; Other: Basic treatments |
| PSCI+Control | Placebo comparator | Control Receives: Other: Basic treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS
The National Institutes of Health Stroke Scale (NIHSS) is a standardized, 11-item assessment tool used to quantify the severity of neurological deficits in patients with acute stroke. Designed to provide objective measurements, it evaluates key domains including level of consciousness (alertness, orientation, and ability to follow commands), gaze, visual fields, facial palsy, motor strength in arms and legs, limb ataxia, sensory function, language (ability to comprehend and express), dysarthria (speech clarity), and extinction/inattention (neglect of sensory or motor stimuli). Each item is scored from 0 (no deficit) to a maximum of 2, 3, or 4 points, depending on the domain, with total scores ranging from 0 (no neurological impairment) to 42 (severe impairment). Widely used in clinical practice, emergency care, and research, the NIHSS helps guide treatment decisions (such as eligibility for thrombolysis or thrombectomy), track neurological changes over time, and predict patient ou
Measured: From enrollment to the end of treatment at 12 weeks
mRS
The Modified Rankin Scale (mRS) is a widely used, standardized tool to assess functional outcome and disability in patients following neurological events, most commonly stroke. Ranging from 0 to 6, it categorizes a patient's level of independence in daily activities based on their ability to perform tasks without assistance. A score of 0 indicates no symptoms or disability, while 1 reflects minor symptoms with no functional impairment. Scores of 2 and 3 denote mild to moderate disability, where patients require some help but can walk unassisted (2) or need significant assistance and may have difficulty walking (3). A score of 4 indicates severe disability, with patients unable to walk or attend to their own bodily needs without constant care. A score of 5 represents complete dependence on others for all aspects of daily living, and 6 signifies death. The mRS is valued for its simplicity, clinical relevance, and ability to track recovery over time, making it essential for guiding p
Measured: From enrollment to the end of treatment at 12 weeks
ADL
The Activities of Daily Living (ADL) scale is a standardized assessment tool used to evaluate an individual's ability to perform essential self-care and daily tasks independently. Focused on functional capacity, it typically includes key activities such as bathing, dressing, grooming, toileting, feeding, transferring (e.g., moving from bed to chair), and maintaining continence. Scoring systems vary slightly across versions (e.g., Barthel Index, Katz Index), but most rate each activity on a scale reflecting independence (e.g., "able to perform without help") to dependence (e.g., "requires full assistance" or "unable to perform"). Total scores quantify the level of functional impairment, with higher scores indicating greater independence and lower scores signaling increased reliance on others. Widely used in healthcare settings-particularly for patients with stroke, dementia, or chronic illness-the ADL scale helps guide care planning, assess recovery progress, determine long-term ca
Measured: From enrollment to the end of treatment at 12 weeks
MoCA
The Montreal Cognitive Assessment (MoCA) is a brief, standardized tool designed to screen for mild cognitive impairment and detect early signs of cognitive decline, often used in clinical settings to evaluate individuals at risk for conditions like Alzheimer's disease or vascular dementia. Comprising 30 points across multiple cognitive domains, it assesses attention and concentration, executive functions (e.g., planning, problem-solving), memory (immediate and delayed recall), language (naming, fluency, comprehension), visuospatial abilities (e.g., copying a complex figure), calculation, and orientation to time and place. Each task is scored based on performance, with points deducted for errors or incomplete responses. A total score of 26 or higher is generally considered normal, while scores below 26 indicate varying degrees of cognitive impairment, with lower scores reflecting more significant deficits. Valued for its sensitivity to mild impairments-often missed by simpler tools
Measured: From enrollment to the end of treatment at 12 weeks
MMSE
The Mini-Mental State Examination (MMSE) is a widely used, brief screening tool designed to assess global cognitive function, primarily to detect cognitive impairment or dementia. Consisting of 30 points, it evaluates key cognitive domains including orientation to time and place (e.g., identifying the current date, season, or location), registration (remembering a list of words), attention and calculation (e.g., serial subtraction or spelling backward), recall (retrieving the earlier list of words), language (naming objects, following commands, writing a sentence, or copying a design), and comprehension. Each task is scored based on accuracy or completion, with points awarded for correct responses. A total score of 27-30 is typically considered within the normal range, 21-26 indicates mild impairment, 10-20 reflects moderate impairment, and scores below 10 signify severe cognitive decline. While valued for its simplicity and widespread use in clinical and research settings, the MM
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (3)
Indicators of pro-inflammatory factors
Changes in indicators of pro-inflammatory factors (including IL-6, IL-1β, TGF-β).
Measured: From enrollment to the end of treatment at 12 weeks
Indicators of blood-brain barrier disruption
Changes in indicators of blood-brain barrier disruption(VE-cadherin、Claudin-5、ZO-1).
Measured: From enrollment to the end of treatment at 12 weeks
Indicators of neuronal injury
Changes in indicators of neuronal injury (NSE, S100β, TDP-43, BDNF, GFAP).
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start7 Mar 2025
- Primary completion30 Jul 2025
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongmei Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongmei Wang, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145294
- Sponsor's protocol ID
- 2024-100-（1）
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced Pluripotent Stem Cells-derived Small Extracellular Vesicles May Promote Neurological Function and Improve Cognitive Impairment in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT07145294
- Acronym / sponsor ID
- 2024-100-（1）
- Conditions
- Cognitive Impairment
- Keywords
- Neuronal damage and cognitive dysfunction induced by acute cerebral ischemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hongmei WangUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 28 Aug 2025 (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.
This study primarily evaluates whether iEV nasal administration can improve neurological impairment and cognitive dysfunction in patients with acute cerebral infarction and cognitive impairment, and preliminarily explores its clinical efficacy.
Detailed description
- It is planned to enroll 40 patients with post - stroke cognitive impairment (PSCI, i.e., acute ischemic stroke (AIS) combined with cognitive impairment) who are hospitalized in the Department of Neurology and Stroke Ward of Shanghai Sixth People's Hospital. These patients should have had an AIS onset within 14 days. They will be divided into the PSCI + treatment group and the PSCI + control group according to a random number table, with 20 patients in each group.
- Enrolled patients need to first complete blood tests such as blood routine and blood biochemistry, as well as skull MRI or skull CT examinations. The total course of treatment for both groups will be 12 weeks.
- Both the treatment group and the control group will receive conventional basic treatment for cerebrovascular diseases. In addition, the treatment group will be given intranasal iEV administration, twice a week, 2 ml each time (with a concentration of 2×10¹⁰/ml), for 12 consecutive weeks. Before treatment and 12 weeks after treatment, the severity of neurological impairment, self - care ability, disability status, and cognitive function status will be evaluated to assess the therapeutic effect of iEV on neurological impairment and cognitive dysfunction in PSCI patients.
- Before intranasal iEV treatment and 12 weeks after treatment, blood samples will be collected respectively to detect changes in indicators such as nerve cell damage, pro - inflammatory factors, angiogenesis, and blood - brain barrier disruption, so as to clarify the neuroprotective mechanism of iEV in PSCI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSCI+iEV | Experimental | Biological: iEV, Other: Basic treatmentsIntranasal administration of iEV, twice a week, 2 ml each time (at a concentration of 2×10¹⁰/ml), for 12 consecutive weeks. |
| PSCI+Control | Placebo comparator | Other: Basic treatmentsControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old.
- Diagnosed with acute ischemic stroke (AIS) according to WHO criteria.
- Time from onset to enrollment ≤ 2 weeks (stable condition after admission and able to cooperate with cognitive assessment), accompanied by manifestations of cognitive impairment, with a score of < 26 on the Montreal Cognitive Assessment (MoCA) scale.
- Cerebral MRI or CT scan shows stroke lesions related to the condition.
- Subjects or their family members voluntarily participate and sign the informed consent form.
Key exclusion criteria (6 listed)
- A diagnosis of cognitive impairment prior to the onset of AIS;
- Presence of aphasia, hearing impairment, visual impairment, dysarthria, or other conditions that prevent completion of neuropsychological assessments;
- Patients with mental illnesses such as depression, anxiety disorder, or schizophrenia;
- Patients with severe diseases of the heart, liver, lungs, kidneys, or other vital organs;
- Patients with disturbed consciousness, a history of long-term alcohol consumption, a history of severe head trauma, or those who cannot cooperate with cognitive function tests for various reasons;
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 |
|---|---|---|
| iEVIntranasal administration of iEV, twice a week, 2 ml each time (at a concentration of 2×10¹⁰/ml), for 12 consecutive weeks. | Biological | PSCI+iEV |
| Basic treatmentsBasic treatments for cerebrovascular diseases such as antiplatelet aggregation, blood pressure control, blood glucose control, blood lipid control, and plaque stabilization. | Other | PSCI+Control, PSCI+iEV |
Primary outcome
NIHSS
Time frame: From enrollment to the end of treatment at 12 weeks
The National Institutes of Health Stroke Scale (NIHSS) is a standardized, 11-item assessment tool used to quantify the severity of neurological deficits in patients with acute stroke. Designed to provide objective measurements, it evaluates key domains including level of consciousness (alertness, orientation, and ability to follow commands), gaze, visual fields, facial palsy, motor strength in arms and legs, limb ataxia, sensory function, language (ability to comprehend and express), dysarthria (speech clarity), and extinction/inattention (neglect of sensory or motor stimuli). Each item is scored from 0 (no deficit) to a maximum of 2, 3, or 4 points, depending on the domain, with total scores ranging from 0 (no neurological impairment) to 42 (severe impairment). Widely used in clinical practice, emergency care, and research, the NIHSS helps guide treatment decisions (such as eligibility for thrombolysis or thrombectomy), track neurological changes over time, and predict patient ou
mRS
Time frame: From enrollment to the end of treatment at 12 weeks
The Modified Rankin Scale (mRS) is a widely used, standardized tool to assess functional outcome and disability in patients following neurological events, most commonly stroke. Ranging from 0 to 6, it categorizes a patient's level of independence in daily activities based on their ability to perform tasks without assistance. A score of 0 indicates no symptoms or disability, while 1 reflects minor symptoms with no functional impairment. Scores of 2 and 3 denote mild to moderate disability, where patients require some help but can walk unassisted (2) or need significant assistance and may have difficulty walking (3). A score of 4 indicates severe disability, with patients unable to walk or attend to their own bodily needs without constant care. A score of 5 represents complete dependence on others for all aspects of daily living, and 6 signifies death. The mRS is valued for its simplicity, clinical relevance, and ability to track recovery over time, making it essential for guiding p
ADL
Time frame: From enrollment to the end of treatment at 12 weeks
The Activities of Daily Living (ADL) scale is a standardized assessment tool used to evaluate an individual's ability to perform essential self-care and daily tasks independently. Focused on functional capacity, it typically includes key activities such as bathing, dressing, grooming, toileting, feeding, transferring (e.g., moving from bed to chair), and maintaining continence. Scoring systems vary slightly across versions (e.g., Barthel Index, Katz Index), but most rate each activity on a scale reflecting independence (e.g., "able to perform without help") to dependence (e.g., "requires full assistance" or "unable to perform"). Total scores quantify the level of functional impairment, with higher scores indicating greater independence and lower scores signaling increased reliance on others. Widely used in healthcare settings-particularly for patients with stroke, dementia, or chronic illness-the ADL scale helps guide care planning, assess recovery progress, determine long-term ca
MoCA
Time frame: From enrollment to the end of treatment at 12 weeks
The Montreal Cognitive Assessment (MoCA) is a brief, standardized tool designed to screen for mild cognitive impairment and detect early signs of cognitive decline, often used in clinical settings to evaluate individuals at risk for conditions like Alzheimer's disease or vascular dementia. Comprising 30 points across multiple cognitive domains, it assesses attention and concentration, executive functions (e.g., planning, problem-solving), memory (immediate and delayed recall), language (naming, fluency, comprehension), visuospatial abilities (e.g., copying a complex figure), calculation, and orientation to time and place. Each task is scored based on performance, with points deducted for errors or incomplete responses. A total score of 26 or higher is generally considered normal, while scores below 26 indicate varying degrees of cognitive impairment, with lower scores reflecting more significant deficits. Valued for its sensitivity to mild impairments-often missed by simpler tools
MMSE
Time frame: From enrollment to the end of treatment at 12 weeks
The Mini-Mental State Examination (MMSE) is a widely used, brief screening tool designed to assess global cognitive function, primarily to detect cognitive impairment or dementia. Consisting of 30 points, it evaluates key cognitive domains including orientation to time and place (e.g., identifying the current date, season, or location), registration (remembering a list of words), attention and calculation (e.g., serial subtraction or spelling backward), recall (retrieving the earlier list of words), language (naming objects, following commands, writing a sentence, or copying a design), and comprehension. Each task is scored based on accuracy or completion, with points awarded for correct responses. A total score of 27-30 is typically considered within the normal range, 21-26 indicates mild impairment, 10-20 reflects moderate impairment, and scores below 10 signify severe cognitive decline. While valued for its simplicity and widespread use in clinical and research settings, the MM
3 secondary outcomes
Indicators of pro-inflammatory factors
Time frame: From enrollment to the end of treatment at 12 weeks
Indicators of blood-brain barrier disruption
Time frame: From enrollment to the end of treatment at 12 weeks
Indicators of neuronal injury
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
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 iEV and Basic treatments in people with Cognitive Impairment, run by Hongmei Wang at 1 site in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongmei Wang, Dr. (+862164369181, 2272454068@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIHSS (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025.