NCT07232563Not yet recruitingPhase 1
Exploratory Study of Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles for the Treatment of Ischemic Stroke
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
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 21 Sept 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Zhujiang Hospital
- Diseases
- Stroke
- NCT number
- NCT07232563
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 9
- From 1 Dec 2025 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe local infection, systemic infection, immunodeficiency, or those currently taking immunosuppressants
Other illness
- 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
Lab values
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 253 Gongye Blvd Middle, Guangzhou, Guangdong, China 510280 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.