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

Inclusion Criteria:

• Age ≥18 years, both genders included.
• Clinical diagnosis of anterior circulation ischemic stroke, and able to receive the investigational product within 48 hours after the onset of stroke symptoms.
• National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (inclusive), with a score of <2 on item Ia of the NIHSS.
• Pre-stroke modified Rankin Scale (mRS) score ≤1.
• The participant voluntarily agrees to participate in this study, signs the informed consent form personally or via a legal guardian, and has good compliance.

Exclusion Criteria:

• Planned or already performed thrombectomy for the current stroke.
• Treatment with neuroprotective agents after the current stroke.
• History of cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation after the current ischemic stroke, and judged by the investigator to be unsuitable for participation in the clinical trial.
• Uncontrolled systemic diseases, including but not limited to: hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes mellitus (acute diabetic complications such as ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, or hypoglycemic coma within the past 3 months, or glycated hemoglobin >8.5%, or poorly controlled blood glucose [blood glucose >16.8 mmol/L or <2.8 mmol/L]), renal disease (eGFR <30 mL/min), liver failure (Child-Pugh Class C), severe heart failure (New York Heart Association [NYHA] Class IV), severe chronic respiratory disease.

• Organ function meeting any one or more of the following criteria:

  1. Absolute neutrophil count (ANC) <1.5×10⁹/L, platelet count (PLT) <100×10⁹/L, hemoglobin (Hb) <90 g/L;
  2. Aspartate aminotransferase (AST) >2.5× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >2.5×ULN, serum total bilirubin (TBIL) >1.5×ULN;
  3. Creatinine (Cr) >1.5×ULN;
  4. For patients not receiving anticoagulant or antithrombotic therapy: international normalized ratio (INR) >1.7 or activated partial thromboplastin time (APTT) >1.25×ULN; for patients receiving anticoagulant or antithrombotic therapy: INR >3.0 or APTT >1.5×ULN.
• Diagnosis of immunodeficiency disease, or long-term use of immunosuppressants or systemic corticosteroids at high doses within a short period before screening.
• Epilepsy, Alzheimer's disease, Parkinson's disease, severe depression, or other neurological or psychiatric disorders that, in the investigator's opinion, could affect the participant's ability to participate in the trial or interfere with study assessments.
• Presence of autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.).
• Inability to undergo cranial CT/MRI examination for any reason (e.g., metallic implants such as cardiac pacemakers, claustrophobia, etc.).
• Participation in another clinical trial of an investigational drug within 3 months before screening.
• Pregnancy, breastfeeding, planned pregnancy, or inability to use effective contraceptive measures.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for inclusion in this study.