Evaluating NouvSoma001 for treating ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, open-label, placebo-controlled, dose-escalation trial aimed at assessing the safety, tolerability, and preliminary efficacy of intravenous administration of human-induced neural stem cell-derived extracellular vesicles (NouvSoma001) in patients with ischemic stroke. The trial consists of two parts: Part 1 focuses on dose escalation with a total of 9 subjects receiving varying doses of the treatment, while Part 2 will involve a larger group of 60 participants randomized to receive either the treatment or a placebo. The study will monitor for dose-limiting toxicities and evaluate the treatment's effectiveness based on clinical outcomes.

Why it matters

Who can join: the full rules

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 traumatic brain injury.
4. Presence of non-vascular diseases causing white matter lesions, such as carbon monoxide poisoning, multiple sclerosis, or adrenoleukodystrophy.
5. 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.
6. Persistent systemic infection, severe local infection, or ongoing use of immunosuppressants.
7. Patients with malignant diseases or an expected survival of less than 5 years.
8. Significant hearing or vision impairments, language disorders, or claustrophobia that would hinder cooperation with neuropsychological assessments and MRI examinations.
9. Contraindications to MRI.
10. Patients unable to comply with follow-up requirements during the study.
11. 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).
12. Patients with alcohol addiction or those testing positive for drug abuse.
13. Patients with a history of severe allergies or known allergy to human biological products.
14. Pregnant or breastfeeding women, and those planning to conceive during the trial period.
15. Participation in other clinical trials within the past 3 months.
16. Patients considered unsuitable for participation by the investigator.

Where it's running

• Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Wei Wang, MD — Tongji Hospital
• Study coordinator: Chuan Qin, MD
• Email: qinchuan712@126.com
• Phone: 86-27-83663337

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.