NCT07084012 A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS
| NCT ID | NCT07084012 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shenzhen Wingor Biotechnology Co., Ltd. |
| Condition | Acute Ischemic Stroke AIS |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-08-27 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase IIa clinical trial with a three-arm design that utilizes randomization, double-blinding, and placebo control. The primary objective of this study is to evaluate the efficacy of single and multiple intravenous infusions of hUC-MSCs injection in patients with AIS. The secondary objective is to assess the safety and tolerability of single and multiple intravenous infusions of hUC-MSCs injection in patients with AIS. The exploratory objective is to investigate the pharmacokinetic and pharmacodynamic characteristics of hUC-MSCs injection in patients with AIS.
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.).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07084012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Ischemic Stroke AIS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07084012 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07084012 currently recruiting?
Yes, NCT07084012 is actively recruiting participants. Contact the research team at xiaohong@wingor.net for enrollment information.
Where is the NCT07084012 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07084012 clinical trial?
NCT07084012 is sponsored by Shenzhen Wingor Biotechnology Co., Ltd.. The trial plans to enroll 60 participants.
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