Tests nasal stem cell vesicles in stroke patients with cognitive impairment
Tests nasal stem cell-derived vesicles in adults with stroke and memory or thinking problems.
Key facts
- Who runs it
- Hongmei Wang
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- Induced Pluripotent Stem Cells-derived Small Extracellular Vesicles May Promote Neurological Function and Improve Cognitive Impairment in Acute Ischemic Stroke Patients
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 40 people, planned
- Started
- 7 Mar 2025
- Planned end
- 1 Jan 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- iEV
- Basic treatments
- Record updated
- 28 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a recent acute ischemic stroke who also have problems with thinking and memory. It tests a nasal treatment called iEV.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke, with no more than 2 weeks between stroke onset and joining. Condition stable after admission. Stroke lesion seen on brain MRI or CT. Thinking problems shown by a MoCA score below 26.
Main reasons for not taking part
- Cognitive impairment diagnosed before the stroke
- Aphasia, hearing or vision problems, or dysarthria that block the thinking tests
- Mental illness such as depression, anxiety disorder or schizophrenia
- Severe disease of the heart, liver, lungs, kidneys or other vital organs
- Disturbed consciousness, long-term alcohol use, severe head injury, or being illiterate
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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 take part
- 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
Where in China
- Shanghai Sixth People's HospitalShanghai, ChinaContact: Shankai YinTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- PSCI+iEVTreatment being tested
Intranasal administration of iEV, twice a week, 2 ml each time (at a concentration of 2×10¹⁰/ml), for 12 consecutive weeks.
Treatment: iEV and Basic treatments
- PSCI+ControlPlacebo, for comparison
Control
Treatment: Basic treatments
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Induced Pluripotent Stem Cells-derived Small Extracellular Vesicles May Promote Neurological Function and Improve Cognitive Impairment in Acute Ischemic Stroke Patients
- Plain-language title
- Tests nasal stem cell vesicles in stroke patients with cognitive impairmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 28 August 2025