Tests NouvSoma001 vesicles in adults with ischemic stroke
Tests an intravenous vesicle treatment for ischemic stroke in adults aged 18 to 75.
Plain-language title generated from the registry record
Registry title: The Safety and Efficacy of NouvSoma001 in Ischemic Stroke
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06612710, who can take part
Where in China
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and TechnologyWuhan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wei Wang
- Trial code
- NCT06612710
- Record updated
- 21 January 2026
- Original description
This is a single-center, randomized, open-label, placebo-controlled, dose-escalation trial. The objective of this research is to evaluate the safety, tolerability, and preliminary efficacy of intravenous administration of human-induced neural stem cell-derived extracellular vesicles (NouvSoma001) in the treatment of ischemic stroke.Read full original descriptionShow less
An Open-label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Ischemic Stroke
This is a single-center, randomized, open-label, placebo-controlled, dose-escalation trial. The objective of this research is to evaluate the safety, tolerability, and preliminary efficacy of intravenous administration of human-induced neural stem cell-derived extracellular vesicles (NouvSoma001) in the treatment of ischemic stroke.
Inclusion: The age of the recruiters ranged from 18 to 75 years; Clinical diagnosis of ischemic stroke, the time of stroke onset is known, and the onset occurred no more than 7 days before enrollment; Magnetic resonance imaging (MRI) or computed tomography (CT) findings consistent with ischemic stroke; At the time of enrollment, the NIHSS score is between 6 and 20; additionally, there is at least one limb with muscle strength ≤ Grade 3; Patients who have the mental capacity to understand and participate in the study; Informed consent was obtained from patients or their legal representatives.
Exclusion: Patients with alcohol addiction or those testing positive for drug abuse; CT indicates intracranial hemorrhage, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation; Patients with Alzheimer's disease, Parkinson's syndrome, or other neurodegenerative disorders; Evidence of brain tumors, epilepsy, or a history of traumatic brain injury; Presence of non-vascular diseases causing white matter lesions, such as carbon monoxide poisoning, multiple sclerosis, or adrenoleukodystrophy; Persistent systemic infection, severe local infection, or ongoing use of immunosuppressants; Patients with malignant diseases or an expected survival of less than 5 years; Significant hearing or vision impairments, language disorders, or claustrophobia that would hinder cooperation with neuropsychological assessments and MRI examinations; Patients with a history of severe allergies or known allergy to human biological products; Severe liver, renal, cardiac, or pulmonary insufficiency, hematologic disorders, or malignant tumors (Liver insufficiency is defined as ALT or AST levels greater than 1.5 times the upper normal limit; renal insufficiency is defined as serum creatinine levels greater than 1.5 times the upper normal limit); Rapid spontaneous neurological improvement during the screening period, defined as a reduction of NIHSS score by ≥ 8 points from symptom onset to the first administration; Contraindications to MRI; Patients unable to comply with follow-up requirements during the study; Pregnant or breastfeeding women, and those planning to conceive during the trial period; Participation in other clinical trials within the past 3 months; Patients considered unsuitable for participation by the investigator.