Tests nasal stem cell vesicles in people with ischemic stroke
Tests intranasal stem cell-derived vesicles in adults with ischemic stroke.
Plain-language title generated from the registry record
Registry title: Exploratory Study of Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles for the Treatment of Ischemic Stroke
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 1
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 70 years old?
Source: NCT07232563, who can take part
Where in China
- 253 Gongye Blvd Middle, Guangzhou, Guangdong, China 510280Guangzhou, ChinaNo longer taking part
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?
Trial details
- Who runs it
- Zhujiang Hospital
- Trial code
- NCT07232563
- Record updated
- 18 November 2025
- Original description
Evaluation of the Safety and Preliminary Efficacy of Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) in Patients for Ischemic StrokeRead full original descriptionShow less
Exploratory Study of Intranasal Administration of Small Extracellular Vesicles Derived From Human Umbilical Cord Mesenchymal Stem Cells hUC-MSC-sEV-001 in the Treatment of Ischemic Stroke Patients
Evaluation of the Safety and Preliminary Efficacy of Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) in Patients for Ischemic Stroke
Inclusion: 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: Patients with severe local infection, systemic infection, immunodeficiency, or those currently taking immunosuppressants; 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); 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 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 clearly lacking the compliance to complete the clinical trial, such as those suffering from uncontrolled mental illness; 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 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; Other situations deemed unsuitable for enrollment by the researchers.