Nasal drops from stem cells aim to heal stroke damage
NCT ID NCT07232563
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests whether nasal drops containing tiny particles from umbilical cord stem cells are safe for people who had an ischemic stroke. Nine patients will receive the drops four times over two weeks, alongside standard care. The main goal is to check for serious side effects, not yet to prove the treatment works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stem cell vesicle nasal drops (hUC-MSC-sEV-001)
- What this could lead to
- If safe and effective, this could point toward a new way to help stroke patients recover without surgery or strong drugs.
- What could go wrong
- This is a very early, tiny safety trial with only 9 people. It may not show any benefit, and side effects or lack of effect are possible.
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 9 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- 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 70 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: * Ischemic Stroke * Age 18-70 years, no gender restriction * Confirmed anterior circulation occlusion by CTA or MR angiography (MRA) * Pre-stroke mRS score of 0-1 * Post-stroke ASPECTS score \>= 6 * Pre-enrollment NIHSS score\>= 6 * Within 24 hours to 14 days of stroke onset * Patients who have not received thrombolysis or endovascular treatment * No significant liver or kidney dysfunction: ALT and AST\<= 2.5 times the upper limit of normal, serum creatinine and blood urea nitrogen \<= 1.25 times the upper limit of normal * No significant cardiac dysfunction * The subject or legal representative can sign the informed consent form and comply with the requirements of the study for administration and follow-up. Exclusion criteria: * Intracranial hemorrhagic conditions observed on cranial CT: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation, etc. * Known severe allergy to contrast agents (excluding mild rash-type allergies) * Known bleeding tendencies (including but not limited to): platelet count \< 100×10\^9/L; received heparin treatment within 48 hours with aPTT \>= 35s; currently taking warfarin with INR \> 1.7 * Patients with brain tumors, or a history of epilepsy and severe head trauma * Patients with other systemic malignancies * Patients with other serious systemic diseases such as immunodeficiency, coagulation disorders, etc. * Patients with Alzheimer's disease, Parkinson's disease, or other neurodegenerative diseases that prevent them from completing follow-up * Patients with severe local infection, systemic infection, immunodeficiency, or those currently taking immunosuppressants * Patients who are positive for hepatitis B surface antigen or currently suffering from other infectious diseases * Patients who have allergic reactions to the drug used in this study or similar drugs * Patients with known allergic constitution * Patients with nasal structural abnormalities or lesions * Patients with cerebrospinal fluid rhinorrhea * Patients who have participated in other clinical trials within the past 3 months * Unwilling or unable to comply with the procedures specified in the protocol * Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use appropriate contraceptive measures * Patients clearly lacking the compliance to complete the clinical trial, such as those suffering from uncontrolled mental illness * Other situations deemed unsuitable for enrollment by the researchers
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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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253 Gongye Blvd Middle, Guangzhou, Guangdong, China 510280
Guangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- 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