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
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 aged 18-70 who recently had an ischemic stroke caused by a blocked artery in the front part of the brain. It tests a nasal treatment made from stem cell-derived vesicles.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Ischemic stroke with a confirmed blockage in the anterior circulation (CTA or MRA). Within 24 hours to 14 days of stroke onset. Post-stroke ASPECTS score 6 or higher and NIHSS score 6 or higher before enrollment. Pre-stroke mRS score of 0-1.
- Earlier treatment
- People who have not received thrombolysis or endovascular treatment can join. People who took other trial drugs in the past 3 months cannot join.
- Biomarker or test result
- Liver and kidney tests must be near normal: ALT and AST up to 2.5 times the upper limit of normal, serum creatinine and blood urea nitrogen up to 1.25 times. No significant heart problems.
Main reasons for not taking part
- Bleeding in the brain on CT, including hemorrhagic stroke
- Known bleeding tendency, such as platelet count < 100×10^9/L
- Brain tumor, epilepsy or severe head injury in the past
- Serious infection, immune deficiency, or taking immunosuppressants; hepatitis B surface antigen positive
- Pregnant or breastfeeding women
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 70 years old?
Source: NCT07232563, who can take part
Where in China
- 253 Gongye Blvd Middle, Guangzhou, Guangdong, China 510280Guangzhou, ChinaContact: Run Zhang, Philosophy DoctorNo 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.