Status:
RECRUITING
The Safety and Efficacy of NouvSoma001 in Ischemic Stroke
Lead Sponsor:
Wei Wang
Collaborating Sponsors:
iRegene Therapeutics Co., Ltd.
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 intraven...
Detailed Description
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-extens...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
July 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06612710
Start Date
July 30 2025
End Date
November 30 2027
Last Update
September 4 2025
Active Locations (1)
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1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology
Wuhan, Hubei, China, 430000