A Clinical Trial of Parkinson's Disease Treatment by HiPSCs Derived Dopaminergic Neural Precursor Cells

Exclusion Criteria

• •1. Patients with atypical Parkinson's disease, such as Parkinson's syndrome or secondary Parkinson's disease.
• •2. Patients with Parkinson's disease with only tremors.
• •3. Patients with severe motor impairment preventing the completion of routine motor tasks.
• •4. Patients with severe neurological deficits caused by other diseases.
• •5. Patients with severe psychiatric symptoms or dementia.
• •6. The Patient who is unwilling or unable to cooperate, incapable of self-assessment, and unable to complete assessments even with the help of a physician.
• •7. Patients who have history of pallidotomy or thalamotomy or deep brain stimulation (DBS) surgery.
• •8. Patients with apomorphine treatment currently .
• •9. Coagulation abnormalities (prothrombin time (PT) or international normalized ratio (INR) \> 1.5×ULN; activated partial thromboplastin time (APTT) \> 1.5×ULN) or receiving anticoagulation therapy.
• •10. Pregnant or lactating female patients and male and female patients who cannot use effective contraception within 1 year after the last study drug use.
• •11. Patients who have participated in other drug or medical device clinical studies within the last 3 months.
• •12. Patients who have used botulinum toxin, phenol, subarachnoid injection of baclofen, or intervention therapy for treating muscle tone disorders or spasticity within the last 6 months.
• •13. Patients who have history of seizures or prophylactic use of antiepileptic drugs.
• •14. Patients who have contraindications for general anesthesia or stereotactic surgery, such as sleep apnea or chronic obstructive pulmonary disease, etc.
• •15. Patients with any other unstable systemic diseases, including active infections, poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg after treatment), unstable angina, congestive heart failure (New York Heart Association NYHA class II or above), or metabolic diseases, etc.
• •16. Patients with alcohol or drug abuse.
• •17. Patients who have used a high dose of benzodiazepines within the last 3 months.
• •18. Patients with severe cognitive impairment, depression, or behavioral disorders, defined as a Mini-Mental State Examination (MMSE) score less than 26 and a Hamilton Depression Rating Scale (HAMD) score greater than 35.
• •19. History of any malignant tumors.
• •20. Patients with hepatitis A, active hepatitis B (HBsAg positive with HBV DNA higher than the upper limit of normal, and excluding hepatitis caused by drugs or other reasons), active hepatitis C (anti-HCV antibody positive with HCV RNA higher than the upper limit of normal), hepatitis E, human immunodeficiency virus (HIV) antibody positive, or syphilis (TP antibody positive).
• •21. Patients with abnormal liver and kidney function laboratory tests during the screening period, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3×ULN, serum creatinine \>1.5×ULN, or total bilirubin \>1.5×ULN.
• •22. Other situations in which the investigator believes that the subject is not suitable for inclusion or cannot tolerate stem cell transplantation surgery.
• •23. PD subjects found to have gene mutations by genetic testing.