The goal of this clinical trial is to evaluate the efficacy, safety, and pharmacodynamic characteristics of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in adults with ischemic stroke in the anterior circulation during the recovery phase. Researchers will compare hUC-MSCs to a placebo to determine whether hUC-MSCs treatment is effective in treating recovery-phase anterior circulation ischemic stroke.
Age ≥18 years and ≤70 years, regardless of gender.
14 to 90 days after ischemic stroke.
Clinical diagnosis of anterior circulation ischemic stroke.
National Institutes of Health Stroke Scale (NIHSS) score is 6-20 points (inclusive), with NIHSS motor arm (item 5) or motor leg (item 6) score of 2-4 points, and NIHSS level of consciousness item (1a) score <2 points.
People who had a history of epilepsy, dementia, Parkinson's disease, severe depression, or other neurological or psychiatric disorders.
Intracranial hemorrhagic conditions.
Pre-stroke mRS score >1.
Severe cardiovascular disease.
Parallel
Placebo
DrugIntravenous injection of placebo
IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells)
DrugIntravenous injection of IxCell hUC-MSC-S
Fugl-Meyer Assessment motor score
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based scale used to evaluate motor impairment. Its motor score, which ranges from 0 to 100, serves as a key parameter for quantifying motor recovery, where a higher score indicates better motor function.
Modified Rankin Scale
The Modified Rankin Scale (mRS) is designed to evaluate the degree of dependence in daily activities rather than specific impairments. The mRS is a simple ordinal scale ranging from 0 to 6, where 0 indicates no symptoms and 6 indicates death. A lower score on the scale signifies a better level of independence and a lower degree of disability.
National Institutes of Health Stroke Scale
The National Institutes of Health Stroke Scale (NIHSS) is designed to evaluate the effects of a stroke on key functional domains such as consciousness, vision, motor strength, sensation, and language.The NIHSS score ranges from 0 to 42, with a higher score indicating more severe neurological deficits.
Barthel Index
The Barthel Index (BI) is commonly employed to evaluate functional disability and monitor rehabilitation progress in patients with chronic conditions or following events such as stroke. The total score ranges from 0 to 100, with a higher score indicating a greater degree of functional independence.
Mini-Mental State Examination
The Mini-Mental State Examination (MMSE) is a standardized screening tool designed to provide a quick assessment of an individual's global cognitive function.The total score ranges from 0 to 30, with a higher score indicating better cognitive performance.
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