Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease

This clinical study is designed to explore the safety and tolerability of UX-DA003. It will also explore if UX-DA003 works to improve motor function in subjects with Parkinson's disease.

Inclusion Criteria: * Aged between 30 and 75 years, regardless of gender * Diagnosed with Parkinson's disease conforming to relevant clinical diagnostic standards with a medical history of 5-20 years * Having received standard anti-PD treatment and been given optimal anti-PD treatment under the guidance of the investigator, but the efficacy has significantly declined * Good response to levodopa medications, the levodopa challenge test (LCT) shows that the maximum improvement rate of the UPDRS-III score exceeds 30% * The modified H\&Y staging (Off period) of ≥2.5 and ≤4, with total daily "off" time \>2 hours * Stable dose of anti-Parkinson' disease drugs for at least 4 weeks prior to screening * Good physical condition or stable concomitant diseases Exclusion Criteria: * The subjects with atypical Parkinson's syndrome or secondary Parkinson's syndrome * Severe systemic diseases or functional impairments * Evidence of active infection or chronic infection, which may pose a risk to the subject * Severe concomitant central nervous system diseases or severe cognitive and psychiatric disorders * Subjects with a history of brain injuries, cerebral vascular malformations, hydrocephalus, brain tumors, or other brain damages as shown by previous Head CT/MRI scans, or subjects with abnormal brain imaging in the striatum or other brain regions that significantly increase surgical risks * Subjects who have participated in clinical trials for stem cell therapy or gene therapy for Parkinson's disease, or have participated in other interventional clinical trials within the last 3 months * Subjects with a history of severe allergies or hypersensitivity reactions, known hypersensitivity to the investigational drug or its ancillary materials, or intolerance to them * Pregnant or breastfeeding women