AzTrials
AzTrials

Ischemic StrokePhase 1NCT07232563

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

A Phase 1 study testing Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy in people with Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Ischemic Stroke
What is being tested?
Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
1 Dec 2025to 7 Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Run Zhang, Philosophy Doctor contact

+86 15820205853

Zrah@163.com

China1 site

  • 253 Gongye Blvd Middle, Guangzhou, Guangdong, China 510280

    Guangzhou, Guangdong, 510000

    Run Zhang, Philosophy Doctor, +86 15820205853, Zrah@163.com

Other trials in China

About this study

Official title: 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

Read the 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.

Conditions
Ischemic Stroke
Being tested
Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy
Keywords
ischemic stroke, stem cell, Extracellular Vesicles
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT07232563
Study groupRoleWhat they receive
Intranasal Administration of hUC-MSC-sEV-001 TherapyExperimentalIntranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy
Receives: Biological: Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 14 (+-2) post-enrollment

Secondary outcomes (8)

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

    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.

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

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

    Measured using the Modified Rankin Scale (mRS) scale. The mRS ranges from 0 to 6, with higher numbers indicating greater disability.

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

  3. Barthel Index within 90 (±7) days

    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.

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

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

    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.

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

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

    Measured using the mRS scale

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

  6. All-cause mortality at 90 (+-7) days

    Contact the patient or their family to confirm survival status

    Measured: Day 90 (+-7)post-enrollment

  7. Changes in infarct volume at 14 (+-2) days compared to baseline

    Using CTA、 CTP and MRI to measure changes in infarct volume in patients

    Measured: baseline, Day 14 (+-2) post-enrollment

  8. Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) Score

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion7 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07232563
Sponsor's protocol ID
2023-KY-343-04
Status last verified
Sep 2025
First submitted
21 Sep 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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: \[zrah@163.com\].

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) Therapy in people with Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Run Zhang, Philosophy Doctor (+86 15820205853, Zrah@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) Related to hUC-MSC-sEV-001 (time frame: Day 14 (+-2) post-enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07232563.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in