An Exploratory Clinical Study of UX-DA001 in Subjects With Idiopathic Parkinson's Disease (NCT06778265) | Clinical Trial Compass
By InvitationPhase 1
An Exploratory Clinical Study of UX-DA001 in Subjects With Idiopathic Parkinson's Disease
China12 participantsStarted 2025-03-01
Plain-language summary
This clinical study is designed to explore the safety and tolerability of UX-DA001. It will also explore if UX-DA001 works to improve motor function in subjects with Parkinson's disease. UX-DA001 manufactured from participant's own cells will differentiate into mature dopaminergic neurons after being transplanted into the brain of the participant.
Who can participate
Age range50 Years – 75 Years
SexALL
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Inclusion criteria
✓. The subjects or their legally acceptable representative understand and comply with the study procedures, agree to participate in the clinical trial, and sign the ICF;
✓. Aged between 50-75 years old, male or female;
✓. Subjects diagnosed with idiopathic PD, 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 LCT shows that the maximum improvement rate of the UPDRS part III score exceeds 30%;
✓. The modified H\&Y scale of clinical "OFF" period is ≥ Stage 3 and ≤ Stage 4;
✓. Taking a stable dosage of anti-PD medications for at least 4 weeks;
✓. Good physical condition or stable concomitant diseases;
Exclusion criteria
✕. PD Subjects in whom previous genetic testing has found a GBA gene mutation or PD Subjects whom the investigator considers unsuitable for participation in this clinical study due to other gene mutations;
✕. Subjects with the atypical Parkinson's syndrome or secondary Parkinson's syndrome;
✕. Subjects with HIV, HBV, HCV, treponema pallidum (TP) infection, or other active infections;
What they're measuring
1
The incidence and and severity of adverse events (AEs) associated with surgery and/or investigational product
Timeframe: within 4 weeks post surgery
2
The incidence and severity of AEs/serious adverse events (SAEs)