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.
Age 18 to 75 years, inclusive, regardless of gender.
Diagnosis of acute ischemic stroke (AIS).
Onset time ≤ 72 hours.
Anterior circulation cerebral infarction.
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.
Parallel
hUC-MSCs treatment (high dose)
Drug2.0×10\^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)
Drug1.0×10\^8 cells per infusion, 3 administrations, on Day 0, Day 7 (±2 days), and Day 14 (±2 days)
Placebo
DrugCell 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.
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.
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.
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.
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.
All-cause mortality rate
All-cause mortality rate
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Shenzhen Wingor Biotechnology Co., Ltd.
Lead sponsor
Beijing Tiantan Hospital
Collaborator
