The Safety and Efficacy of NouvSoma001 in Ischemic Stroke
An Open-label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Ischemic Stroke
Wei Wang
69 participants
Nov 30, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria16
- 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.
- 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.
- 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.
- Contraindications to MRI.
- Patients unable to comply with follow-up requirements during the study.
- 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).
- Patients with alcohol addiction or those testing positive for drug abuse.
- Patients with a history of severe allergies or known allergy to human biological products.
- 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.
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Interventions
extracellular vesicles derived from human induced neural stem cell for intravenous injection（4×10\^9 particles/kg）
extracellular vesicles placebo (4×10\^9 particles/kg)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06612710