A Phase I Trial of Umbilical Cord Mesenchymal Stromal Cells for Acute Ischemic Stroke

Incidence of DLT (Dose-Limiting Toxicity) events;

All adverse events/serious adverse events during the trial;

All-cause mortality

Proportion of participants with an Modified Rankin Scale (mRS) score of 0-2

The modified Rankin Scale (mRS) is a widely used clinical outcome measure that assesses the degree of disability or dependence in the daily activities of patients who have suffered a stroke or other neurological conditions. It is a simple, 7-level ordinal scale ranging from 0 to 6: 0 - No symptoms at all. 1. \- No significant disability: able to perform all usual activities despite some symptoms. 2. \- Slight disability: unable to carry out all previous activities but able to look after own affairs without assistance. 3. \- Moderate disability: requires some help but able to walk without assistance. 4. \- Moderately severe disability: unable to walk or attend to bodily needs without assistance. 5. \- Severe disability: bedridden, incontinent, requiring constant nursing care. 6. \- Dead. A higher score indicates more severe disability. The mRS is the most common primary endpoint in acute stroke clinical trials, with a score of 0-2 at 90 days often defined as a "good outcome.

Proportion of participants with a ≥4-point improvement in National Institutes of Health Stroke Scale (NIHSS) score from baseline

The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to objectively quantify the severity of neurological deficits in patients with stroke. It consists of 15 items, including assessments of consciousness, eye movements, visual fields, facial palsy, motor and sensory function, language, speech, and neglect. Each item is scored, with a total score ranging from 0 to 42. Higher scores indicate more severe neurological impairment. The NIHSS is widely used in clinical practice and research to evaluate stroke severity, guide treatment decisions, and predict patient outcomes.

Change from baseline in National Institutes of Health Stroke Scale(NIHSS) score

Proportion of participants with a Barthel Index ≥95

The Barthel Index (BI) is a standardized ordinal scale used to measure a person's performance in activities of daily living (ADL). It assesses 10 basic functions, including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers (e.g., bed to chair), mobility, and stair climbing. Each item is scored based on the amount of physical assistance required, with total scores typically ranging from 0 to 100 (or 0-20 in some versions). It is widely used in geriatrics, rehabilitation, and stroke research to evaluate functional independence and track changes over time.A higher Barthel Index score indicates greater functional independence (less need for assistance), while a lower score reflects greater disability and dependency. For example, a score of 100 means the patient is fully independent in basic ADL.

mmunogenicity: Human Leukocyte Antigen (HLA) antibodies.