Exploratory Study of Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles for the Treatment of Ischemic Stroke

Zhujiang Hospital

Status and phase

Not yet enrolling

Phase 1

Conditions

Ischemic Stroke

Treatments

Biological: Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07232563

2023-KY-343-04

Details and patient eligibility

About

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

Full description

Based on adhering to the GCP principles of national clinical trial research and the standardized processes of CROs, this study aims to evaluate the safety and preliminary efficacy of hUC-MSC-sEV-001 in treating ischemic stroke by recruiting a small sample population. Additionally, the study will seek to determine an appropriate dosage, laying the foundation for subsequent research.

Enrollment

9 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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)
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