An Exploratory Clinical Study of UX-DA001 in Subjects With Idiopathic Parkinson's Disease (NCT06778265) | Clinical Trial Compass
Active — Not RecruitingPhase 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 range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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;
. Subjects infected with HTLV, EBV or CMV whose infection renders their blood cells unsuitable for cell product preparation;
. Subjects with a known hereditary disorder;
. Subjects with any history of malignancy;
. Subjects with other serious systemic diseases or functional disorders;
. Accompanied by other serious central nervous system diseases or serious cognitive and mental disorders;