NCT07102342 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.

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 5 participants in total. It began in 2026-01-12 with a primary completion date of 2027-09.

Brief Summary

This is a phase 1/2 clinical study to evaluate the safety, tolerability, feasibility, and preliminary efficacy of NouvNeu001 in patients with advanced Parkinson's Disease.

Eligibility Criteria

Inclusion Criteria: Age • Male or female patient must be 30 to 75 years of age inclusive, at the time of signing the informed consent form (ICF). Type of Patient and Disease Characteristics * Diagnosis of PD between past 4 to 20 years (meet MDS 2015 clinical diagnostic criteria for PD). * H-Y staging (Appendix III) for "OFF" episodes is 2.5-4.0. * MDS-UPDRS-III score \> 35, and positive for the Acute levodopa challenge test (ALCT) (improvement \> 30% for MDS UPDRS-III staging from OFF episodes to ON episodes) over two screening period visits. Baseline scores will be computed as the means of two screening period visits. * No significant change in UPDRS-III scores between the two visits during the screening period. * Patients who take stable doing of dopamine drug for at least 4 weeks prior to receiving the study drug. * No significant change in dose and dosing schedule of the prescribed medicines for PD during the screening period. * Medically suitable for neurosurgery under general anesthesia. * Acceptable laboratory test values during screening and prior to transplantation (Day 0): * Absolute neutrophil count ≥ 2.0 × 109/L * White blood cell count ≥ 4.0 × 109/L * Platelet count ≥ 100 × 109/L * Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) * Total bilirubin ≤ 1.5 x ULN * Serum creatinine ≤ 1.5 x ULN * eGFR ≥ 50 mL/min/1.73 m2 * Agree to postpone any additional neurosurgical procedures, including DBS, until completion of the 12-month follow-up study (unless recommended by a neurologist). * Agree not to participate in any other therapeutic intervention study within 24 months after neurosurgery. * Able to participate in all study visits and evaluations, including brain/spine MRI, CT and PET scan. Weight • Body mass index (BMI) within the range of 18\~32 kg/m2 (inclusive) with a minimum body weight of 45 kg at screening. Sex and Contraceptive/Barrier Requirements • Contraceptive use by men and women for 12 months after neurosurgery should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Informed Consent * Able to understand the rationale of the clinical trial and sign the ICF. Other Inclusion Criteria * Agree not to receive COVID-19 vaccine within 14 days before neurosurgery, and not to receive any other vaccine within 30 days after neurosurgery Exclusion Criteria: 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. Other Exclusion Criteria * 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

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