An Early Phase 1 interventional study of UX-DA003 in PARKINSON DISEASE (Disorder), sponsored by The First Affiliated Hospital of Anhui Medical University. Recruiting at 1 site in China. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by The First Affiliated Hospital of Anhui Medical University · Early Phase 1, Interventional, and Treatment
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.
This study is a single-arm, open-label, dose-escalation exploratory clinical trial aimed at evaluating the safety, tolerability, and preliminary efficacy of different doses of UX-DA003 injections for treating patients with Parkinson's disease. Eligible participants are mid-to-late stage PD patients who have shown significant decline in response after standard PD treatment and have not undergone DBS surgery.
The study planned two dose groups: a low-dose group receiving 3.6×10\^6 cells per side (6 patients) and a high-dose group receiving 5.4×10\^6 cells per side (6 patients). A total of 12 patients are planned to be enrolled, with each patient receiving only one dose of UX-DA003 for bilateral putamen cell transplantation.
A Safety Monitoring Committee (SMC) has been set up for the study, which can decide based on safety data whether to include additional patients after the sentinel cases, start enrollment in the next dose group, explore other dose levels, increase the number of patients in any dose group, or stop/modify the trial protocol.
Enrollment for each dose group proceeds from low to high. Each dose group includes sentinel cases, where the first patient is monitored for 4 weeks after cell transplantation. Only after the SMC reviews the safety data can subsequent patients receive cell transplantation.
Four weeks after the last patient in each dose group receives transplantation, the SMC will conduct an overall safety assessment for all patients and discuss the next steps.
The trial visit schedule includes a screening period (D-30 to D-15), baseline period (D-14 to D-1), surgery and post-op observation period (D0 to D28), follow-up period (M3 to M24), and long-term follow-up period (Y3 to Y5). Screening and baseline periods involve screening checks, baseline assessment, and pre-op examinations. Surgery takes place on D0, with hospitalization required the day before (D-1) and on post-op day 4. Patients return to the hospital on day 14 (D14) and day 28 (D28) for follow-up. Follow-up visits occur at 3, 6, 9, 12, 18, and 24 months to assess safety and efficacy. Patients completing the 24-month follow-up enter the long-term follow-up period, with annual visits up to 5 years post-surgery.
During the trial, patients are allowed to continue using regular anti-Parkinson medications at a stable dose to manage PD symptoms.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →The First Affiliated Hospital of Anhui Medical University is the lead sponsor of 43 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: UX-DA003
UX-DA003 (Human Allogeneic iPSC-derived Midbrain Dopaminergic Progenitor cells) is used for treating patients with PD via implanting into bilateral putamina under stereotactic neurosurgery.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Within 6 months after administration
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Within 24 months after administration
Changes in 18F-FP-CIT uptake detected by positron emission tomography (PET)
Time frame: Within 24 months after administration
Changes in MDS-UPDRS scores
Time frame: Within 24 months after administration
Changes in modified H&Y staging
Time frame: Within 24 months after administration
Changes in daily levodopa equivalent dose (LED)
Time frame: Within 24 months after administration
Changes in average daily 'off' and 'on' duration while awake
Time frame: Within 24 months after administration
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The First Affiliated Hospital of Anhui Medical University