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NCT07145294RecruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 28 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
10 Aug 2025
Start date
7 Mar 2025
Primary completion date
30 Jul 2025
Lead sponsor
Hongmei Wang
Diseases
Stroke
NCT number
NCT07145294

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 40
  • From 7 Mar 2025 to the primary completion date, 30 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • A diagnosis of cognitive impairment prior to the onset of AIS;

Other illness

  • 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;

Other

  • illiterate patients.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai Sixth People's Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.