The Safety and Efficacy of NouvSoma001 in Ischemic Stroke

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT06612710

Run by

Wei Wang

People needed

69

Starts

2025-11-30

Expected to finish

2027-11-30

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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