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

NCT07145294 | Recruiting Phase 1 DMC

• 1 other identifier: 2024-100-（1）
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 preliminarily explores its clinical efficacy.

Conditions

Cognitive Impairment

Keywords

Neuronal damage and cognitive dysfunction induced by acute cerebral ischemia

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (3)

• Indicators of pro-inflammatory factors

  From enrollment to the end of treatment at 12 weeks

• Indicators of blood-brain barrier disruption

  From enrollment to the end of treatment at 12 weeks

• Indicators of neuronal injury

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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.

Biological: iEV; Other: Basic treatments

PSCI+Control

PLACEBO COMPARATOR

Control

Other: Basic treatments

Interventions

iEV BIOLOGICAL

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

PSCI+iEV

Basic treatments OTHER

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

PSCI+Control; PSCI+iEV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hongmei Wang: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, 200000, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Hongmei Wang, Dr.

CONTACT

+862164369181; 2272454068@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician of the Department of Neurology, Shanghai Sixth People's Hospital, and Youth Council Member of the Chinese Stroke Association

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 28, 2025
• Study Start: March 7, 2025
• Primary Completion: July 30, 2025
• Study Completion: January 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)