A Safety and Tolerability Study of Human Forebrain Neural Progenitor Cells Injection (hNPC01) in Subjects With Chronic Ischemic Stroke

Exclusion Criteria

• •1. Has any psychological or psychiatric condition that would significantly interfere with the study;
• •2. History of more than one symptomatic stroke \[transient ischemic attacks (TIAs) are not exclusionary\];
• •3. Has signs and symptoms of intracerebral hernia or elevated intracerebral pressure;
• •4. History of epilepsy or current use of antiepileptic drugs, including any seizures in the 3 months prior to screening;
• •5. Intracerebral aneurysm or arteriovenous malformation; hemorrhagic transformation of ischemic loci within 2 weeks of screening; moyamoya disease (MMD); autosomal dominant cerebrovascular disease with subcortical infarction and leukoencephalopathy; patients with giant cerebral infarction (MRI confirms that the infarct size is greater than 150 cm\^3); CT angiography (CTA) shows severe stenosis in vital vessels in head or neck;
• •6. Patients with severely impaired motor function of one limb caused by previous neurological diseases (such as PD, motor neuron disease, arthritis, or anatomical deformity, etc.); Patients who have undergone any major surgery 8 weeks prior to screening;
• •7. Severe muscular atrophy or muscular dystrophy;
• •8. Patients with severe cardiovascular diseases within 3 months of screening, such as malignant arrhythmia, atrial fibrillation, acute myocardial infarction, congestive heart failure, etc. (cardiac function grade III-IV using the New York Heart Association (NYHA) classification for heart failure);
• •9. Patients participating in other drug or device clinical trials within the last 3 months or 5 half-lives of the drug, whichever is longer;
• •10. Receiving other cell transfusions or alike other than transfusion in the past 5 years;
• •11. Any of the following diseases or conditions:
• •1. Severe coagulopathy, preoperative INR (International Normalized Ratio)\>1.4;
• •2. Patients with positive HLA (Human Leukocyte Antigen) before surgery;
• •3. Severe active infection with poor drug control before surgery;
• •4. Severe dermatitis or severe skin damage in the operation area;
• •5. History of tumors other than benign tumors; history of brain tumors, including meningiomas;
• •6. Laboratory values meeting any of the following criteria (a second retest can be performed for patients with a first test result outside the specified range, and the patients can be included in the study if the second test results are evaluated by the investigator as normal):
• •* Hemoglobin \<90 g/L
• •* White blood cell count (WBC)\<3.5×10\^9/L
• •* Neutrophil count \<1.5×10\^9/L
• •* Platelet count \<100×10\^9/L
• •* Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) 2 times the upper limit of normal (ULN)
• •* Serum creatinine \>1.2 × ULN
• •7. Uncontrolled or poorly controlled hypertension despite medicine (systolic blood pressure \>160 mmHg, or diastolic blood pressure \>100 mmHg) or hypotension requiring pressor therapy;
• •8. Uncontrolled or poorly controlled diabetes despite medicine (glycosylated hemoglobin A1c \> 8%);
• •9. Active gastrointestinal bleeding;
• •10. Positive active pulmonary tuberculosis (if positive γ-interferon release test in screening period and the safety risk is within a controllable range after evaluation by the investigators, the participant can be enrolled);