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

NCT ID: NCT07145294

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2026-01-01

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.

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 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.

2. 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.

3. 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.

4. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PSCI+iEV

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

Group Type: EXPERIMENTAL

iEV

Intervention Type: BIOLOGICAL

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

Basic treatments

Intervention Type: OTHER

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

PSCI+Control

Control

Group Type: PLACEBO_COMPARATOR

Basic treatments

Intervention Type: OTHER

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

Interventions

iEV

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

Intervention Type: BIOLOGICAL

Basic treatments

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hongmei Wang

OTHER

Sponsor Role: lead

Responsible Party

Hongmei Wang

Chief Physician of the Department of Neurology, Shanghai Sixth People's Hospital, and Youth Council Member of the Chinese Stroke Association

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shanghai Sixth People's Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongmei Wang, Dr.

Role: CONTACT

2272454068@qq.com

+862164369181

Facility Contacts

Shankai Yin

Role: primary

liuyuanec@163.com

+862164369181

Role: backup

liuyuanec@163.com

Other Identifiers

2024-100-（1）

Identifier Type: -

Identifier Source: org_study_id