Tests NouvSoma001 vesicles in adults with ischemic stroke
Tests an intravenous vesicle treatment for ischemic stroke in adults aged 18 to 75.
Plain-language title generated from the registry record
Registry title: The Safety and Efficacy of NouvSoma001 in Ischemic Stroke
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a recent ischemic stroke to test the safety of NouvSoma001, given into a vein.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Ischemic stroke confirmed by MRI or CT, with known onset no more than 7 days before enrollment. NIHSS score between 6 and 20, and at least one limb with muscle strength of Grade 3 or less.
- Earlier treatment
- Cannot have taken part in another clinical trial within the past 3 months.
Main reasons for not taking part
- Bleeding in the brain on CT, including hemorrhagic stroke
- Other brain diseases such as Alzheimer's disease, Parkinson's syndrome, brain tumors, epilepsy or past traumatic brain injury
- Ongoing serious infection or use of immunosuppressants
- Severe liver, kidney, heart or lung problems, or cancer
- Pregnant or breastfeeding women, or women planning to conceive during the trial
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06612710, who can take part
Where in China
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and TechnologyWuhan, ChinaContact: Chuan QiunTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Wei Wang
- Trial code
- NCT06612710
- Record updated
- 21 January 2026
- Original description
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.Read full original descriptionShow less
An Open-label Exploratory Clinical Trial to Assess the Safety and Efficacy of NouvSoma001 in the Treatment of Ischemic Stroke
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.
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: Patients with alcohol addiction or those testing positive for drug abuse; 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; 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; Patients with a history of severe allergies or known allergy to human biological products; 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); 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; Contraindications to MRI; Patients unable to comply with follow-up requirements during the study; 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.