Status:
RECRUITING
Induced Pluripotent Stem Cells-derived Small Extracellular Vesicles May Promote Neurological Function and Improve Cognitive Impairment in Acute Ischemic Stroke Patients
Lead Sponsor:
Hongmei Wang
Conditions:
Cognitive Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 p...
Detailed Description
1. 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 Ne...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07145294
Start Date
March 7 2025
End Date
January 1 2026
Last Update
August 28 2025
Active Locations (1)
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1
Shanghai Sixth People's Hospital
Shanghai, China, 200000