Evaluating NouvSoma001 for treating ischemic stroke

An Open-label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Ischemic Stroke

This study is testing a new treatment using special cells to see if it can help people recover better after having an ischemic stroke.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06612710 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who have experienced an ischemic stroke within the last 7 days and have specific neurological deficits.

Not a fit: Patients with hemorrhagic stroke, neurodegenerative disorders, or significant brain injuries are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from ischemic stroke.

How similar studies have performed: While this approach is novel, other studies involving stem cell-derived therapies for stroke have shown promising results, indicating potential for success.

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 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 this trial is running

Wuhan, Hubei

• 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

Conditions Ischemic Stroke; extracellular vesicles