Acute Ischemic Stroke AISPhase 2NCT07084012
A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS
A Phase 2 study testing hUC-MSCs treatment (high dose) and hUC-MSCs treatment (low dose) in people with Acute Ischemic Stroke AIS, run by Shenzhen Wingor Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Ischemic Stroke AIS
- What is being tested?
- hUC-MSCs treatment (high dose) and hUC-MSCs treatment (low dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2025to 30 Dec 2028
- Phase
- Phase 2
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- Presence of brain tumor or history of malignancy.
- 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.
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- 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.
- Systemic corticosteroid ( > 10 mg/day prednisone equivalent) or immunosuppressive drug treatment within 14 days before receiving the investigational drug or during the trial.
- 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).
- 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.
- Participation in an interventional clinical trial within the past 3 months, or receipt of other cell therapy (excluding blood transfusion).
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Yongjun Wang, Prof., 86-010-59978538, yongjunwang111@aliyun.com
About this study
Official title: 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.
Read the detailed description
Stroke is a disease with high incidence, disability rate, and mortality rate, ranking as the second leading cause of death globally and the leading cause in China. Acute ischemic stroke (AIS) accounts for approximately 60%-80% of all strokes. The most effective treatments for AIS are revascularization therapies within the time window, including intravenous thrombolysis with tissue plasminogen activator (t-PA) and mechanical thrombectomy. Although t-PA thrombolysis is effective, it can cause reperfusion injury, exacerbating a series of inflammatory damages. Additionally, the success rate of thrombolysis and thrombectomy is closely related to the onset time. The time window within 4.5 hours or 6 hours is considered effective for rescuing the ischemic penumbra, and only a minority of AIS patients can receive thrombolytic therapy. Some patients have contraindications to thrombolysis, and endovascular treatment is only suitable for large vessel occlusion. Furthermore, in China, low public awareness of early disease recognition, insufficient prehospital emergency capabilities, in-hospital emergency delays, and other factors lead to delayed AIS treatment and a low thrombolysis rate.
Studies have shown that mesenchymal stem cells can reduce the infarct area and alleviate blood-brain barrier damage by regulating the microenvironment of damaged brain tissue, alleviating inflammatory responses, and promoting angiogenesis, neurogenesis, and neurovascular repair. This study aims to evaluate the efficacy, safety, and tolerance of single and multiple intravenous infusions of hUC-MSCs injection in the treatment of AIS patients.
- Conditions
- Acute Ischemic Stroke AIS
- Being tested
- hUC-MSCs treatment (high dose), hUC-MSCs treatment (low dose), Placebo
- Keywords
- hUC-MSCs, AIS,, Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hUC-MSCs treatment (high dose)Drug
Also called hUC-MSCs injection
2.0×10^8 cells per infusion, single administration on D0. Infusion of cell medium placebo on Day 7 (±2 days), and Day 14 (±2 days).
hUC-MSCs treatment (low dose)Drug
Also called hUC-MSCs injection
1.0×10^8 cells per infusion, 3 administrations, on Day 0, Day 7 (±2 days), and Day 14 (±2 days)
PlaceboDrug
Cell medium, 3 administrations, on Day 0, Day 7 (±2 days), and Day 14 (±2 days)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects receive one infusion of hUC-MSCs infusions. Receives: Drug: hUC-MSCs treatment (high dose) |
| Group 2 | Experimental | Subjects receive three infusions of hUC-MSCs. Receives: Drug: hUC-MSCs treatment (low dose) |
| Placebo Control Group | Placebo comparator | Subjects receive three infusions of cell medium placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with an mRS score of 0-2 at different follow-up visits after treatment.
Evaluate each patient's modified Rankin Scale (mRS) score, with a total score ranging from 0 to 6, where a higher score indicates a poorer outcome. Determine the proportion of patients with an mRS score of 0-2 at different follow-ups after treatment.
Measured: 360 days
The proportion of subjects with an NIHSS improvement of ≥4 points at different follow-up visits after treatment
Evaluate each patient's National Institutes of Health Stroke Scale (NIHSS) score at different follow-up time points after treatment.
The NIHSS score ranges from 0 to 42, with higher scores indicating more severe neurological impairment.
Determine the proportion of subjects with an improvement of ≥4 points in their NIHSS score.
Measured: 90 days
Changes in NIHSS score from baseline at different follow-up visits after treatment
Evaluate each patient's National Institutes of Health Stroke Scale (NIHSS) score before treatment and at different follow-up time points after treatment.
The NIHSS score ranges from 0 to 42, with higher scores indicating more severe neurological impairment.
Determine the changes in NIHSS scores relative to the baseline.
Measured: 90 days
Trends in the distribution of mRS scores (0-6) at different follow-up visits after treatment
Evaluate the modified Rankin Scale (mRS) score for each patient, with a total score ranging from 0 to 6, where a higher score indicates a poorer outcome. Determine the distribution trend of mRS scores (0-6) at different follow-up visits after treatment.
Measured: 360 days
The proportion of subjects with a Barthel Index (BI) score of ≥95 at different follow-up visits after treatment
Evaluate the Barthel Index of Activities of Daily Living (BI) score for each patient, which ranges from 0 to 100, with higher scores indicating better independence and less dependence of the patient.
Determine the proportion of subjects with a BI score of ≥95 at different follow-up visits after treatment.
Measured: 360 days
Changes in Fugl-Meyer Motor Function Assessment Scale score from baseline at different follow-up visits after treatment
Evaluate the Fugl-Meyer Motor Function Assessment Scale score for each patient before and after treatment.
The scale consists of 50 items, with a maximum total score of 100, where a higher score indicates a better outcome.
Determine the change in Fugl-Meyer Motor Function Assessment Scale score from baseline at different follow-up visits after treatment.
Measured: 360 days
Secondary outcomes (2)
Adverse Events
Adverse Events: Including AEs , SAEs , any AE leading to discontinuation of treatment, any adverse reaction occurring in subjects within 180 days, and neurologic deterioration related to the drug.
Measured: 360 days
All-cause mortality rate
All-cause mortality rate
Measured: 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start27 Aug 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke AISStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Wingor Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084012
- Sponsor's protocol ID
- WG103-AIS-Ⅱa
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No