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UX-DA003 in Parkinson's Disease
NCT07733349Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2026
- Primary completion
- Aug 2029
- Countries
- 1
- Sponsor
- UniXell Biotechnology
- Drugs
- UX-DA003
- Conditions
- Parkinson's disease (PD)
01
Overview
Phase 2, open-label, single-arm trial of UX-DA003 in Parkinson's disease (PD), sponsored by UniXell Biotechnology. Primary endpoint: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) at 6 months. Started Sep 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
UX-DA003
Single dose of UX-DA003 for bilateral putamenal cell transplantation. Phase I includes two dosage groups; Phase II uses the RP2D.
03
Who it enrols
Patients aged 30-75 with Parkinson's disease for 5-20 years, experiencing significant decline in efficacy of standard anti-PD treatments, with good response to levodopa, modified H&Y staging 2.5-4, and >2 hours daily 'off' time. Excludes patients with prior DBS, stem cell/gene therapy, severe systemic/CNS diseases, or active infections.
04
Endpoints
Primary
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Secondary
Changes in 18F-FP-CIT uptake detected by positron emission tomography (PET)
Changes in MDS-UPDRS scores
Changes in modified H&Y staging
Changes in daily levodopa equivalent dose (LED)
Changes in average daily 'off' and 'on' duration while awake
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