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

NCT07232563 | Not Yet Recruiting Phase 1

• 1 other identifier: 2023-KY-343-04
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke

Keywords

ischemic stroke; stem cell; Extracellular Vesicles

Outcome Measures

Primary Outcomes (1)

• Dose-Limiting Toxicity (DLT) Related to hUC-MSC-sEV-001

  Dose-Limiting Toxicity (DLT) Related to hUC-MSC-sEV-001 Includes: 1. Grade 3-4 severe adverse events occurring on day 14 (+-2), graded according to Common Terminology Criteria for Adverse Events （CTCAE） V5.0; 2. NIHSS score increase of ≥4 from baseline on day 14 (+-2); NIHSS score assessed by a professional rehabilitation physician; 3. Symptomatic intracranial hemorrhage occurring on day 14 (+-2); detected via CT scan and patient symptom presentation.

  Day 14 (+-2) post-enrollment

Secondary Outcomes (8)

• Serious adverse events related to the investigational drug within 90 (+-7) days

  At baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment

• Distribution of Modified Rankin Scale (mRS) Scores within 90 (+-7) days

  baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment

• Barthel Index within 90 (±7) days

  baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment

• Five-level, five-dimensional EuroQol (EQ-5D-5L)

  baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment

• Proportion of Modified Rankin Scale (mRS) Scores of 0-2 within 90 (+-7) days

  baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment

Study Arms (1)

Intranasal Administration of hUC-MSC-sEV-001 Therapy

EXPERIMENTAL

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

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

Interventions

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

Experimental drug: hUC-MSC-SEV-001 nasal drops derived from small extracellular vesicles of human umbilical cord mesenchymal stem cells Treatment plan: On the basis of conventional treatment, hUC-MSC-SEV-001 nasal drops will be administered: hUC-MSC-SEV-001 will be administered via nasal drip for a total of 4 times, with a dosage of 1 × 10 \* 11articles per dose. The patient will receive one dose on the day of enrollment, and another dose of hUC-MSC-SEV-001 will be administered on the 2nd, 3rd, and 4th days after enrollment.

Intranasal Administration of hUC-MSC-sEV-001 Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

253 Gongye Blvd Middle, Guangzhou, Guangdong, China 510280

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Run Zhang, Philosophy Doctor

CONTACT

+86 15820205853; Zrah@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: November 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 7, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE
• Time Frame: The data from this trial will be shared through the public data repository"ResMan" after the study results are published.

Locations

CN (1)