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NCT06612710 | RECRUITING | Ischemic Stroke

The Safety and Efficacy of NouvSoma001 in Ischemic Stroke
Sponsor:

Wei Wang

Information provided by (Responsible Party):

Wei Wang

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 intravenous administration of human-induced neural stem cell-derived extracellular vesicles (NouvSoma001) in the treatment of ischemic stroke.

Condition or disease

Ischemic Stroke

Intervention/treatment

extracellular vesicles derived from human induced neural stem cell for intravenous injection

a placebo of extracellular vesicles derived from human induced neural stem cell for intravenous injection

Phase

PHASE1

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-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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 69 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Open-label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Ischemic Stroke
Actual Study Start Date : 2025-07-30
Estimated Primary Completion Date : 2025-11-30
Estimated Study Completion Date : 2027-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
The Safety and Efficacy of NouvSoma001 in Ischemic Stroke

Location Details

NCT06612710

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Locations

RECRUITING

China, Hubei

Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology

Wuhan, Hubei, China, 430000