Tests umbilical cord stem cell infusion in people with acute ischemic stroke
Tests stem cells from umbilical cords given by vein to adults with acute stroke.
Plain-language title generated from the registry record
Registry title: A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with an acute ischemic stroke (a stroke caused by a blocked blood vessel in the brain) that started within the last 72 hours.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Acute ischemic stroke in the front part of the brain's blood supply (anterior circulation), started 72 hours ago or less. NIHSS stroke score between 8 and 20, and consciousness item 1a score of 1 or less.
- Earlier treatment
- People who have had or are planned to have clot-dissolving treatment (thrombolysis) or clot removal (thrombectomy) for this stroke cannot join. No other cell therapy, and no steroid or immune-suppressing drugs in the 14 days before the study drug.
Main reasons for not taking part
- Bleeding in the brain (intracranial hemorrhage)
- Brain tumor or any history of cancer
- Liver or kidney problems on screening tests
- Severe infection such as sepsis or severe pneumonia
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07084012, who can take part
Where in China
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen Wingor Biotechnology Co., Ltd.
- Trial code
- NCT07084012
- Record updated
- 29 July 2026
- Original description
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.Read full original descriptionShow less
A Phase IIa Randomized, Blinded, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in the Treatment of Acute Ischemic Stroke (AIS)
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.
Inclusion: Age 18 to 75 years, inclusive, regardless of gender; Diagnosis of acute ischemic stroke (AIS); Onset time ≤ 72 hours; Anterior circulation cerebral infarction; Modified Rankin Scale (mRS) score ≤ 1 before the onset of this stroke; National Institutes of Health Stroke Scale (NIHSS) score between 8 and 20 (inclusive) at screening, and NIHSS item 1a (level of consciousness) score ≤ 1; The subject or their legal guardian has signed the informed consent form.
Exclusion: 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; Systemic corticosteroid ( > 10 mg/day prednisone equivalent) or immunosuppressive drug treatment within 14 days before receiving the investigational drug or during the trial; Participation in an interventional clinical trial within the past 3 months, or receipt of other cell therapy (excluding blood transfusion); Planned or already undergone thrombolysis or thrombectomy for this stroke; 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; 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; Presence of brain tumor or history of malignancy; History of severe cardiovascular disease, which the investigator deems unsuitable for participation in this clinical trial; Severe infection, including sepsis, septic shock, severe pneumonia, etc; 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); 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; 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.); 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.