The Safety and Efficacy of NouvSoma001 in Ischemic Stroke
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: 1. The age of the recruiters ranged from 18 to 75 years. 2. Clinical diagnosis of ischemic stroke, the time of stroke onset is known, and the onset occurred no more than 7 days before enrollment. 3. Magnetic resonance imaging (MRI) or computed tomography (CT) findings consistent with ischemic stroke. 4. 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. 5. Patients who have the mental capacity to understand and participate in the study. 6. Informed consent was obtained from patients or their legal representatives. Exclusion Criteria: 1. CT indicates intracranial hemorrhage, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation. 2. Patients with Alzheimer's disease, Parkinson's syndrome, or other neurodegenerative disorders. 3. Evidence of brain tumors, epilepsy, or a history of traumat