A Phase 1/2 interventional study of UX-DA003 in Parkinson's Disease, sponsored by Shanghai UniXell Biotechnology Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Shanghai UniXell Biotechnology Co., Ltd · Phase 1/2, 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 an open-label, multicenter, two-stage, Phase I/II clinical trial. Phase I study is a single-arm, open-label, dose-escalation clinical study aimed at evaluating the safety, tolerability, and preliminary efficacy of UX-DA003 transplantation therapy for PD patients across different dosage groups, as well as determining the recommended Phase II dose (RP2D). Eligible participants include PD patients who have experienced significant decline in response to standard anti-PD treatment and have not undergone DBS surgery. The study plans to establish two dosage. A total of 12 patients are planned for enrollment. Each patient will undergo a single dose of UX-DA003 for bilateral putamenal cell transplantation.
Phase II study is a single-arm, open-label, single-dose study aimed at further evaluating the efficacy and safety of UX-DA003 for the treatment of PD patients at the RP2D dose, providing evidence for Phase III confirmatory clinical studies. The enrollment population is the same as in the clinical Phase I. This phase includes only one dose group, with the dose being the recommended dose (RP2D) determined in the Phase I stage.
The trial visit schedule includes screening period (D-30\~D-8), baseline period (D-7\~D-1), surgery and postoperative observation period (D0\~D28), and follow-up period (M3\~M24).Patients who have completed the 24-month follow-up will enter the long-term follow-up period.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Shanghai UniXell Biotechnology Co., Ltd is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Shanghai UniXell Biotechnology Co., Ltd