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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
253 Gongye Blvd Middle, Guangzhou, Guangdong, China 510280
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.