A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS

Launched by SHENZHEN WINGOR BIOTECHNOLOGY CO., LTD. · Jul 17, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment for people who have had an acute ischemic stroke, which is a type of stroke caused by a blockage in the blood flow to the brain. The study is testing the safety and effectiveness of giving patients an infusion (a slow injection into a vein) of special cells called human umbilical cord mesenchymal stem cells (hUC-MSCs). These cells may help the brain heal after a stroke. The trial will compare one or multiple infusions of these cells to a placebo (a treatment without the active cells) to see if the stem cell therapy helps patients recover better.

To join the trial, participants need to be between 18 and 75 years old and have had a recent stroke within the last 72 hours that affects the front part of the brain. They should have mild to moderate stroke symptoms and must not have had certain treatments like clot-busting drugs or surgery for the stroke. People with other serious health issues, such as brain bleeding, severe infections, or certain neurological diseases, will not be eligible. If accepted, participants will receive either the stem cell treatment or placebo through an intravenous infusion and will be closely monitored for safety and improvement. This study is not yet recruiting, but it aims to find out if this new treatment can help stroke patients recover safely and more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 to 75 years, inclusive, regardless of gender.
• • 2. Diagnosis of acute ischemic stroke (AIS).
• • 3. Onset time ≤ 72 hours.
• • 4. Anterior circulation cerebral infarction.
• • 5. Modified Rankin Scale (mRS) score ≤ 1 before the onset of this stroke.
• • 6. National Institutes of Health Stroke Scale (NIHSS) score between 8 and 20 (inclusive) at screening, and NIHSS item 1a (level of consciousness) score ≤ 1.
• • 7. The subject or their legal guardian has signed the informed consent form.
• Exclusion Criteria:
• • 1. Planned or already undergone thrombolysis or thrombectomy for this stroke.
• • 2. History of epilepsy (excluding secondary epilepsy that does not currently require medication), Parkinson's disease, Alzheimer's disease, severe depression, or other diseases that the investigator deems would affect the subject's participation in the trial or the assessment of efficacy.
• • 3. Presence of intracranial hemorrhagic disease (e.g., intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma, etc.). If only petechial bleeding is present, the investigator may determine whether the subject is suitable for inclusion in the study.
• • 4. Computed tomography (CT) or magnetic resonance imaging (MRI) of the head showing a large ischemic area in the middle cerebral artery territory or midline shift greater than 1 cm on head CT/MRI, and the investigator assesses a high likelihood of surgical intervention or poor prognosis.
• • 5. Presence of brain tumor or history of malignancy.
• • 6. Liver or kidney insufficiency during the screening period: Aspartate aminotransferase (AST) \> 2.5 × upper limit of normal, alanine aminotransferase (ALT) \> 2.5 × upper limit of normal, estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m².
• • 7. History of severe cardiovascular disease, which the investigator deems unsuitable for participation in this clinical trial.
• • 8. Severe infection, including sepsis, septic shock, severe pneumonia, etc.
• • 9. Systemic corticosteroid ( \> 10 mg/day prednisone equivalent) or immunosuppressive drug treatment within 14 days before receiving the investigational drug or during the trial.
• • 10. History of alcohol abuse within the past year (defined as an average of more than 2 units per day (1 unit = 10 mL ethanol, i.e., 1 unit = 200 mL of 5% alcohol beer or 25 mL of 40% alcohol spirits or 85 mL of 12% alcohol wine).
• • 11. Pregnant or breastfeeding women; or unwillingness to use reliable contraception (e.g., condoms) throughout the study period, or plans to donate sperm or eggs, or have plans for pregnancy.
• • 12. Participation in an interventional clinical trial within the past 3 months, or receipt of other cell therapy (excluding blood transfusion).
• • 13. Other situations in which the investigator deems the patient unsuitable for participation in this study (including but not limited to non-compliance with the principle of patient benefit, poor patient compliance, unacceptable laboratory abnormalities, etc.).