NCT07733349
Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
Not Yet Recruiting · Phase 1, Phase 2 · Shanghai UniXell Biotechnology Co., Ltd · registry updated 2026-07-29
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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
- 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
Exclusion
- 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