A Phase 2 interventional study of hUC-MSCs treatment (high dose) and hUC-MSCs treatment (low dose) in Acute Ischemic Stroke AIS, sponsored by Shenzhen Wingor Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Shenzhen Wingor Biotechnology Co., Ltd. · Phase 2, Interventional, and Treatment
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.
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Shenzhen Wingor Biotechnology Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects receive one infusion of hUC-MSCs infusions.
Drug: hUC-MSCs treatment (high dose)
Subjects receive three infusions of hUC-MSCs.
Drug: hUC-MSCs treatment (low dose)
Subjects receive three infusions of cell medium placebo.
Drug: Placebo
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).
Also known as: hUC-MSCs injection
1.0×10\^8 cells per infusion, 3 administrations, on Day 0, Day 7 (±2 days), and Day 14 (±2 days)
Also known as: hUC-MSCs injection
Cell medium, 3 administrations, on Day 0, Day 7 (±2 days), and Day 14 (±2 days)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 360 days
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.
Time frame: 360 days
All-cause mortality rate
All-cause mortality rate
Time frame: 360 days
Plan to share: No
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Shenzhen Wingor Biotechnology Co., Ltd.