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

Inclusion Criteria:

1. Subject or his/her legal guardian must understand and voluntarily sign an InformedConsent Form (ICF) prior to any study-related assessments/procedure being conducted;
2. Age 30-65 years old, male or female; at the time of signing the ICF;
3. Female patients with negative blood pregnancy test and women in the reproductiveperiod need to adopt effective contraceptive methods; Or has become infertile (menopausal for at least 2 years or has undergone hysterectomy, oophorectomy, orsterilization surgery); Male patients who have no plans to donate sperm or havechildren within 30 days before the trial and six months after the trial end need toadopt effective contraceptive methods;
4. Documented history of completed ischemic stroke in the subcortical and/or corticalregions of the middle cerebral artery (MCA) or lenticulostriate arteries confirmed byhead CT or magnetic resonance imaging;
5. 6 - 60 months since the acute onset of ischemic stroke, accompanied by unilateral limbmotor dysfunction, with/without aphasia;
6. Modified Rankin Score 3, or 4 points at time of screening;
7. FMMS scores lower than 55 and score changes no greater than 5 points in twoassessments at least 3 weeks apart before surgery;
8. NIHSS score change is no greater than 4 points in two assessments at least 3 weeksapart before surgery;
9. Subject must have maintained regular physical therapy and rehabilitation prior toenrollment and be able to continue physical therapy and rehabilitation aftertreatment.

Exclusion Criteria:

1. Has any psychological or psychiatric condition that would significantly interfere withthe study;
2. History of more than one symptomatic stroke [transient ischemic attacks (TIAs) are notexclusionary];
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 inthe 3 months prior to screening;
5. Intracerebral aneurysm or arteriovenous malformation; hemorrhagic transformation ofischemic loci within 2 weeks of screening; moyamoya disease (MMD); autosomal dominantcerebrovascular disease with subcortical infarction and leukoencephalopathy; patientswith giant cerebral infarction (MRI confirms that the infarct size is greater than 150cm^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 previousneurological diseases (such as PD, motor neuron disease, arthritis, or anatomicaldeformity, etc.); Patients who have undergone any major surgery 8 weeks prior toscreening;
7. Severe muscular atrophy or muscular dystrophy;
8. Patients with severe cardiovascular diseases within 3 months of screening, such asmalignant arrhythmia, atrial fibrillation, acute myocardial infarction, congestiveheart failure, etc. (cardiac function grade III-IV using the New York HeartAssociation (NYHA) classification for heart failure);
9. Patients participating in other drug or device clinical trials within the last 3months 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:
12. Severe coagulopathy, preoperative INR (International Normalized Ratio)>1.4;
13. Patients with positive HLA (Human Leukocyte Antigen) before surgery;
14. Severe active infection with poor drug control before surgery;
15. Severe dermatitis or severe skin damage in the operation area;
16. History of tumors other than benign tumors; history of brain tumors, includingmeningiomas;
17. Laboratory values meeting any of the following criteria (a second retest can beperformed for patients with a first test result outside the specified range, andthe patients can be included in the study if the second test results areevaluated 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) 2times the upper limit of normal (ULN)
• Serum creatinine >1.2 × ULN

7. Uncontrolled or poorly controlled hypertension despite medicine (systolic bloodpressure >160 mmHg, or diastolic blood pressure >100 mmHg) or hypotensionrequiring pressor therapy;
8. Uncontrolled or poorly controlled diabetes despite medicine (glycosylatedhemoglobin A1c > 8%);
9. Active gastrointestinal bleeding;
10. Positive active pulmonary tuberculosis (if positive γ-interferon release test inscreening period and the safety risk is within a controllable range afterevaluation by the investigators, the participant can be enrolled);
11. Active hepatitis B patients, including positive Hepatitis B surface antigens (HBsAg), and patients who had hepatitis B virus (HBV) infection in the past andwhose HBV infection has disappeared (defined as hepatitis B core antibody [HBcAb]positive and HBsAg negative) meet the inclusion criteria;
12. Hepatitis C virus antibody positive;
13. Syphilis infected subjects (subjects who test positive for Treponema pallidumserology need to undergo further non-Treponema pallidum serology tests. If thetest result is negative, the investigators determine that patients who havepreviously been infected with syphilis but have recovered meet the inclusioncriteria);
14. HIV antibody positive
15. Primary or secondary immunodeficiency; or any medical condition involvingimmunosuppressants intake;
16. Persistent MRI artifacts, no clear MRI images can be obtained before or after surgery;patients with contraindications to MRI or PET scans;
17. Contraindications to cyclosporine or methylprednisone sodium succinate or prednisone;
18. Neither able or willing to participate in physical and/or professional therapy asscheduled, nor to return to the hospital on time for follow-up visits as planned;
19. Inability to discontinue antiplatelet or anticoagulant medications within theperioperative period;
20. Existence of recent drug abuse or alcohol abuse or any other medical conditions that,in the opinion of the investigator, could interfere with the clinical study results orcompromise the clinical condition of the subject, or which in the opinion of theinvestigator, could increase procedural complications.