Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-S) in the Treatment of Ischemic Stroke

Prior treatment

• Current or previous epilepsy, dementia, Parkinson's disease, major depression, or other neurological disorders or mental illnesses that the investigator believes will affect their ability to participate in the study or affect the study evaluation;
• Hepatitis B virus surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive for HBV-DNA, positive for hepatitis C virus antibody (HCVAb), treponema pallidum antibody (TPAb/RPR) or human immunodeficiency virus antibody (HIV), or within 14 days prior to receiving the test drug treatment,The emergence of any infected persons in need of systematic anti-infective treatment;
• Positive blood pregnancy test results for female subjects of reproductive age within 7 days prior to receiving the experimental drug treatment;All women of reproductive age, fertile men or their spouses who refused to use appropriate contraception (including at least one barrier contraceptive) throughout the study period, and lactating women;
• Those who required systemic corticosteroids (\> 10mg/ day prednisone therapeutic dose) or other immunosuppressive agents within 14 days prior to receiving the trial drug or during the study period;
• Patients who used butylphthalein within 3 weeks before receiving the experimental drug;
• participated in any clinical trial and took any investigational drug within 3 months prior to receiving the investigational drug treatment (or the last time receiving the investigational drug did not exceed 5 half-lives, whichever is longer);
• Patients who had severe trauma or major surgery within 3 months before receiving the experimental drug treatment, or who plan to undergo surgery during the trial period;Patients with a history of blood transfusion within 3 months before receiving the experimental drug treatment;
• Those who had a history of drug abuse or alcoholism within 1 year before receiving the experimental drug treatment;
• Those who have previously received other stem cell treatments;

Other illness

• Current or past intracranial hemorrhagic diseases (such as: cerebral hemorrhage, epidural hematoma, subdural hematoma, subarachnoid hemorrhage, ventricle hemorrhage, traumatic cerebral hemorrhage, etc.) or cerebral tumors, history of brain trauma, encephalitis and other symptoms leading to apoplexy;
• Current or past severe cardiovascular disease；
• Patients with pulmonary embolism, interstitial pneumonia, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other severe lung infections or other lung diseases (except those caused by stroke, bed rest after stroke or stroke treatment);
• Allergic constitution or history, or allergic to the test drug or any component of the test drug;
• Participants with other severe, acute, or chronic medical conditions that may increase the patient's risk or may interfere with the interpretation of the test results are judged by the investigator to be unsuitable for clinical trials.

Lab values

• Have any other clinically serious medical conditions currently or in the past that the investigators judge unsuitable for inclusion in this study, including but not limited to severe liver (e.g., cirrhosis, etc.), kidney (e.g., kidney diseases requiring hemodialysis or peritoneal dialysis, etc.), blood (e.g., hemophilia with bleeding tendencies, etc.), endocrine (e.g.,Diabetes mellitus with difficult blood glucose control (blood glucose \> 16.8mmol/L or \< 2.8mmol/L), or complicated with severe neurovascular complications, etc.), immune system (active or uncontrolled autoimmune diseases, primary or secondary immune deficiencies, etc.), malignant tumors (except cured non-melanoma skin cancer, cervical or breast ductal carcinoma in situ), etc.;
• Organ function level meet the following any one or more:
  • absolute neutrophil cell count (ANC) \< 1.5×109/L, platelet (PLT) \< 100×109/L, hemoglobin (Hb) \< 90g/L; Aspertate aminotransferase (AST) \> 2.5×normal limit (ULN) and/or alanine aminotransferase (ALT) \> 2.5×ULN, serum total bilirubin (TBIL) \> 1.5×ULN; Creatinine (Cr) \> 1.5×ULN; The international normalized ratio (INR) for those who did not receive anticoagulant or antithrombotic therapy \> 1.7 or activated partial thromboplastin time (APTT) \> 1.25×ULN, the international normalized ratio(INR) for those using anticoagulant or antithrombotic therapy \> 3.0 or activated partial thromboplastin time (APTT) \> 1.50×ULN.

Other

• Patients with MRI contraindications;

• 18 to 80 years old, both sexes;
• Diagnosed with ischemic stroke of the anterior circulation at 12-24 weeks after the first stroke symptom onset (including W12 and W24);
• National Institutes of Health Stroke Scale (NIHSS) score 6-20 points, and NlHSS score item 1a \< 2 points;
• Life expectancy ≥ 12 months;
• Understand and comply with the study process, with informed consent form voluntarily signed by the patient or the authorized representatives.