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

November 14, 2025 updated by: Zhujiang Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Run Zhang, Philosophy Doctor
  • Phone Number: +86 15820205853
  • Email: Zrah@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • 253 Gongye Blvd Middle, Guangzhou, Guangdong, China 510280
        • Contact:
          • Run Zhang, Philosophy Doctor
          • Phone Number: +86 15820205853
          • Email: Zrah@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intranasal Administration of hUC-MSC-sEV-001 Therapy
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose-Limiting Toxicity (DLT) Related to hUC-MSC-sEV-001
Time Frame: Day 14 (+-2) post-enrollment

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious adverse events related to the investigational drug within 90 (+-7) days
Time Frame: At baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment
The occurrence of serious adverse events related to the investigational drug will be assessed according to CTCAE v5.0, based on monitoring of the patient's vital signs (pulse, blood pressure, respiration, and body temperature), as well as laboratory tests including complete blood count, urinalysis, liver and kidney function, glucose and lipid metabolism, coagulation profile, serum electrolytes, tumor markers, and electrocardiogram.
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
Time Frame: baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment
Measured using the Modified Rankin Scale (mRS) scale. The mRS ranges from 0 to 6, with higher numbers indicating greater disability.
baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment
Barthel Index within 90 (±7) days
Time Frame: baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment
Measured using the Barthel Index. The total score of the Barthel Index ranges from 0 to 100 points. A higher Barthel Index score indicates a better (more positive) outcome, while a lower score indicates a poorer (more challenging) outcome.
baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment
Five-level, five-dimensional EuroQol (EQ-5D-5L)
Time Frame: baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment
Measured using the Five-level, five-dimensional EuroQol (EQ-5D-5L). It has two main scores with distinct ranges. The Index Score (Utility Score) comes from mapping responses on 5 health dimensions to a standardized scale. Its minimum is typically -0.594 to -0.101 (varies by region; negatives mean health worse than death for some), and maximum is 1.0 (full health, no limitations). The Visual Analog Scale (VAS) Score is a subjective self-rating on a 100mm vertical line, with 0 ("Worst imaginable health") as minimum and 100 ("Best imaginable health") as maximum. For both scores, higher means better HRQoL.
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
Time Frame: baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment
Measured using the mRS scale
baseline, Day 7 (+-1), Day 14 (+-2), and Day 90 (+-7)post-enrollment
All-cause mortality at 90 (+-7) days
Time Frame: Day 90 (+-7)post-enrollment
Contact the patient or their family to confirm survival status
Day 90 (+-7)post-enrollment
Changes in infarct volume at 14 (+-2) days compared to baseline
Time Frame: baseline, Day 14 (+-2) post-enrollment
Using CTA、 CTP and MRI to measure changes in infarct volume in patients
baseline, Day 14 (+-2) post-enrollment
Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) Score
Time Frame: baseline, Day 7 (+-1) and Day 14 (+-2)post-enrollment
Measured using the National Institutes of Health Stroke Scale (NIHSS). Its total score range spans from a minimum of 0 points (indicating no detectable neurological deficits, suggesting minimal or no stroke-related impairment) to a maximum of 42 points (representing severe, widespread neurological dysfunction, often associated with profound stroke-related disability); regarding the scoring standard, a higher score means a worse outcome.
baseline, Day 7 (+-1) and Day 14 (+-2)post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-KY-343-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data from this trial will be shared through the public data repository"ResMan" after the study results are published. The dataset includes all raw data, processed data, and statistical analysis codes. Data will be anonymized to ensure participant privacy. The data can be accessed via the following link: [www.medresman.org.cn]. For any inquiries, please contact the corresponding author: [zrah@163.com].

IPD Sharing Time Frame

The data from this trial will be shared through the public data repository"ResMan" after the study results are published.

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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