Exploratory Study of Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles for the Treatment of Ischemic Stroke
NCT ID: NCT07232563
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
9 participants
INTERVENTIONAL
2025-12-01
2027-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intranasal Administration of hUC-MSC-sEV-001 Therapy
Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy
Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy
Experimental drug: hUC-MSC-SEV-001 nasal drops derived from small extracellular vesicles of human umbilical cord mesenchymal stem cells Treatment plan: On the basis of conventional treatment, hUC-MSC-SEV-001 nasal drops will be administered: hUC-MSC-SEV-001 will be administered via nasal drip for a total of 4 times, with a dosage of 1 × 10 \* 11articles per dose. The patient will receive one dose on the day of enrollment, and another dose of hUC-MSC-SEV-001 will be administered on the 2nd, 3rd, and 4th days after enrollment.
Interventions
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Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy
Experimental drug: hUC-MSC-SEV-001 nasal drops derived from small extracellular vesicles of human umbilical cord mesenchymal stem cells Treatment plan: On the basis of conventional treatment, hUC-MSC-SEV-001 nasal drops will be administered: hUC-MSC-SEV-001 will be administered via nasal drip for a total of 4 times, with a dosage of 1 × 10 \* 11articles per dose. The patient will receive one dose on the day of enrollment, and another dose of hUC-MSC-SEV-001 will be administered on the 2nd, 3rd, and 4th days after enrollment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Zhujiang Hospital
OTHER
Responsible Party
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Locations
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253 Gongye Blvd Middle, Guangzhou, Guangdong, China 510280
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2023-KY-343-04
Identifier Type: -
Identifier Source: org_study_id
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