Could stem cell vesicles help heal the brain after a stroke?
NCT ID NCT06612710
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new treatment called NouvSoma001 for people who have had an ischemic stroke within the past week. The treatment uses tiny particles from stem cells, given through an IV, to see if it is safe and might help the brain recover. About 69 participants will be randomly assigned to receive either the active therapy or a placebo, and researchers will monitor side effects and brain healing over several months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NouvSoma001 (extracellular vesicles from human induced neural stem cells)
- What this could lead to
- If it works, this could point toward a new treatment that helps the brain repair itself after a stroke, potentially reducing long-term disability.
- What could go wrong
- This is a very early Phase 1 trial with only 69 people, so it is primarily checking safety. The therapy may not improve outcomes, and there could be unknown side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 69 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tongji Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology
RECRUITINGWuhan, Hubei, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to catch a hidden heart rhythm after stroke
- Blood test may reveal who recovers after a stroke
- Can a smart bracelet and app stop a second stroke?
- Pharmacist and coach team takes aim at blood pressure after stroke