The Safety and Efficacy of NouvSoma001 in Ischemic Stroke

This is a single-center, randomized, open-label, placebo-controlled, dose-escalation trial. This study will consist of 2 parts, with Part 1 being a dose-escalation study and Part 2 being a dose-extension study based on the results of Part 1. Part 1 will follow a traditional 3+3 dose-escalation design, enrolling a total of 9 subjects. Cohort 1: receive 4×10^9 particles/kg, Cohort 2: receive 8×10^9 particles/kg, and Cohort 3: receive 1.6×10^10 particles/kg. If no dose-limiting toxicities (DLT) are observed within 2 weeks after the initial administration, a new cohort will be enrolled at the next higher dose level. If DLTs are observed in 1 participant, another 2 participants will be treated at the same dose level. Dose escalation will cease if DLTs are observed in more than 33% of the participants. In Part 2, the remaining 60 participants will be randomized in a 2:1 ratio to the treatment and placebo groups, with the dose level determined by the Data Safety Monitoring Board based on the results of Part 1.

Inclusion criteria

• 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 criteria

• 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.