Actively Recruiting
The Safety and Efficacy of NouvSoma001 in Ischemic Stroke
Led by Wei Wang · Updated on 2026-01-21
69
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
W
Wei Wang
Lead Sponsor
I
iRegene Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Safety and Efficacy of NouvSoma001 in Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Clinical diagnosis of ischemic stroke with known onset time within 7 days before enrollment
- MRI or CT scan confirming ischemic stroke
- NIH Stroke Scale (NIHSS) score between 6 and 20 at enrollment
- At least one limb with muscle strength grade 3 or lower
- Mental capacity to understand and participate in the study
- Signed informed consent obtained from patient or legal representative
You will not qualify if you...
- Evidence of intracranial hemorrhage on CT, including hemorrhagic stroke or hematomas
- Diagnosis of Alzheimer's disease, Parkinson's syndrome, or other neurodegenerative disorders
- Brain tumors, epilepsy, or history of traumatic brain injury
- Non-vascular causes of white matter lesions such as carbon monoxide poisoning or multiple sclerosis
- Rapid neurological improvement defined as NIHSS score reduction of 8 or more points from symptom onset to first treatment
- Persistent or severe infections, or ongoing immunosuppressant use
- Malignant diseases or expected survival less than 5 years
- Significant hearing or vision impairment, language disorders, or claustrophobia affecting assessments
- Contraindications to MRI
- Inability to comply with follow-up requirements
- Severe liver, kidney, heart, or lung failure, hematologic disorders, or malignant tumors
- Alcohol addiction or positive drug abuse test
- History of severe allergies or allergy to human biological products
- Pregnancy, breastfeeding, or planning pregnancy during the trial
- Participation in another clinical trial within past 3 months
- Considered unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
C
Chuan Qin, MD
CONTACT
C
Chuan Qin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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