Nasal stem cell–derived vesicles to improve thinking and recovery after acute ischemic stroke

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

This tests whether twice-weekly nasal doses of stem cell–derived extracellular vesicles can help thinking, daily function, and neurological recovery in adults who recently had an ischemic stroke and now have cognitive problems.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai 6th People's Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07145294 on ClinicalTrials.gov

What this trial studies

This randomized Phase 1/2 trial will enroll 40 adults hospitalized with acute ischemic stroke and new cognitive impairment within 14 days of onset, randomized 1:1 to receive standard care with or without intranasal iPSC-derived small extracellular vesicles (iEVs). The treatment group receives 2 mL intranasal iEVs (2×10^10/mL) twice weekly for 12 weeks while both groups receive conventional cerebrovascular care. Neurological impairment, self-care ability, disability status, and cognitive function will be measured at baseline and 12 weeks, and blood biomarkers related to neuronal damage, inflammation, angiogenesis, and blood–brain barrier integrity will be collected pre- and post-treatment. Brain imaging (MRI or CT) and routine blood tests are required at baseline to confirm eligible stroke lesions and safety.

Who should consider this trial

Good fit: Adults (≥18) hospitalized with acute ischemic stroke within 14 days who have new cognitive impairment (MoCA < 26), can cooperate with assessments, and provide informed consent are ideal candidates.

Not a fit: Patients with pre-existing cognitive impairment, severe organ failure, disturbed consciousness, major communication or sensory deficits, or serious psychiatric illness are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the treatment could improve cognitive function and neurological recovery after acute ischemic stroke, potentially increasing independence in daily activities.

How similar studies have performed: Preclinical animal studies of extracellular vesicles after stroke show promising improvements in brain repair and cognition, but clinical evidence in humans remains very limited.

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.

Where this trial is running

Shanghai

• Shanghai Sixth People's Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Hongmei Wang, Dr.

Conditions Cognitive Impairment; Neuronal damage and cognitive dysfunction induced by acute cerebral ischemia