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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Sixth People's Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Hongmei Wang, Dr.
• Email: 2272454068@qq.com
• Phone: +862164369181

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.