RecruitingPhase 1Phase 2NCT07145294

Induced Pluripotent Stem Cells-derived Small Extracellular Vesicles May Promote Neurological Function and Improve Cognitive Impairment in Acute Ischemic Stroke Patients

Sponsor

Hongmei Wang

Enrollment

40 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

Cognitive Impairment

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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.

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Interventions

BIOLOGICALiEV

Intranasal administration of iEV, twice a week, 2 ml each time (at a concentration of 2×10¹⁰/ml), for 12 consecutive weeks.

OTHERBasic treatments

Basic treatments for cerebrovascular diseases such as antiplatelet aggregation, blood pressure control, blood glucose control, blood lipid control, and plaque stabilization.