This Clinical Trial is Designed to Evaluate the Safety, Tolerability, Feasibility and Preliminary Efficacy of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in Patients With Parkinson's Disease.

Exclusion Criteria51

• Medical Conditions
• Atypical Parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, familial parkinsonism) Prior/Concomitant Therapy
• Patients who have had previous pallidotomy, DBS surgery, striatal or extrapyramidal surgery, brain stereotaxy, prior surgical or radiation therapy to the brain or spinal cord, or other brain surgery; as well as other surgical procedures that, in the investigator's judgment, could interfere with participation in this study.
• Patients who have a previous head CT/MRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery.
• Patients who have had previous cellular therapy.
• Patients who have used glucocorticoids for an extended period (≥14 days) and at high doses (equivalent to prednisone ≥ 20 mg/day or other glucocorticoids at equivalent doses) within 3 months prior to signing the ICF. (excluding topical treatment)
• Patients who have used immunosuppressive drugs for an extended period (≥14 days) within 3 months prior to signing the ICF.
• Patients who have used antipsychotics, such as antidepressants, antimanic drugs, etc. within 3 months prior to signing the ICF and are deemed by the investigator to potentially impact the study assessment.
• Patients who have used botulinum toxin or other drugs for dystonia or muscle spasticity within 6 months prior to signing the ICF and are deemed by the investigator to potentially impact the study assessment.
• Prior/Concurrent Clinical Study Experience
• Patients who are participating in other clinical trials, or have been enrolled in other clinical studies within 3 months prior to the screening
• Patients with poor compliance based on clinical evaluation of the investigator. Diagnostic Assessments
• Patients with a history of dementia or a severe cognitive disorder; or those with obvious dementia or congnitive impairment detected during screening; MDS-UPDRS congnitive impairment score (section 1.1) \> 3 point at screening; or patinets with poor compliance, inability to accurately keep diary, and/or inability to sign ICF due to dementia.
• Severe depression as defined by HAMD ≥ 24 at screening.
• Severe anxiety as defined by HAMA ≥ 29 at screening.
• Patients with a history of psychiatric disorders that, in the investigator's opinion, make them unsuitable for participation; or patients with a history of suicidal ideation or suicide attempts within the past year or currently (including actual attempts, interrupted attempts, or failed attempts).
• Patients with abnormal coagulation (prothrombin time ≥ 1.5 ULN, activated partial thromboplastin time ≥ 1.5 ULN), or abnormal INR at screening.
• Patients cannot temporarily suspend anti-platelet agents or other anti-coagulant medications at least 5 days prior to investigational drug administration surgery.
• Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to signing the ICF.
• Patients with current or history of following disease
• severe heart failure (congestive heart failure of New York Heart Association Class II or above), unstable angina pectoris, and myocardial infarction
• severe arrhythmia, including but not limited to second- or third-degree atrioventricular block, or prolonged QT interval.
• Long QT Syndrome.
• cardiovascular surgery (cardiac, vascular stent surgery, angioplasty).
• stroke or transient ischemic attack within 3 months prior to signing the ICF, as determined by the investigator to be unsuitable to participate the study.
• subarachnoid hemorrhage
• primary mitochondrial disorder, multiple sclerosis, or other neurodegenerative diseases such as Alzheimer's disease
• major vascular diseases (aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis), as determined by the investigator to be unsuitable to participate the study.
• previous or current malignant tumors
• immune disfunction, including autoimmune disease or immunocompromised state
• traumatic brain injury with loss of consciousness and residue neurologic symptoms
• active epilepsy or currently on anti-epileptic drugs
• Hypertensive patients with poorly controlled blood pressure (defined as blood pressure above 160/100 mmHg despite antihypertensive drugs treatment) and patients with severe postural hypotension
• Diabetic patients with poorly controlled blood glucose (glycosylated hemoglobin \> 9.0%, or fasting plasma glucose (FPG) ≥ 11.1mmol/L)
• Patients with clinically significant abnormalities in kidney or liver function at screening.
• Patient with clinically significant abnormalities in immunological tests at screening
• Patients with surgical contraindications (such as those with cochlear implant, cardiac pacemaker, cardiac defibrillator, stereotactic nucleus pallidotomy; Patients who have had unilateral or bilateral intraparenchymal implantation of cellular products, or other surgical procedures within 6 months before screening which, in the opinion of the investigator, have an impact on this trial; Patients with other neurosurgical contraindications)
• Patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD) (FEV1% \< 50%)
• Patients with serious infections, requiring antibiotic treatment within 2 weeks prior to signing the ICF
• Patients with any active infectious disease, including but not limited to positive for human immunodeficiency virus, SARS Covid-19 virus, syphilis antibody, quantitative HCV-RNA testing, quantitative HBV-DNA testing greater than normal range for test results, or untreated tuberculosis; any other active infection that, in the investigator's opinion, may affect the participant's ability to take part in the study or could impact study outcomes.
• Patients with alcohol or drug addiction
• Patients with contraindications or a history of allergy to any medicines used during the neurosurgical procedure.
• Patients with contraindication or a history of allergy to any medicines used during the study, such as immunosuppressants, levodopa, etc, or any of their components; Patients who are allergic to similar drugs or other macrolides.
• Female of childbearing potential who are not surgically sterilized/premenopausal/unwilling to use medically approved effective contraception during the study and lactating women; men who are not surgically sterilized/unwilling to use medically approved effective contraception during the study
• Patients who have received electric shock therapy within 30 days prior to the investigational drug administration surgery
• Patients who are participating in other clinical trials, or have been enrolled in other clinical studies within 3 months prior to the screening
• Patients with poor compliance based on clinical evaluation of the investigator
• Patients who are being treated with drugs such as neuroleptics, apomorphine, or levodopa/carbidopa infusion therapy
• Patients with severe dyskinesia in both "ON" and "OFF" drug states
• Patients who have received or will receive a live vaccine within 4 weeks prior to the study
• Patients with significant medical conditions, or with other conditions that, in the opinion of the investigator, are unsuitable to participate in the study