Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease

Sponsor
Shanghai UniXell Biotechnology Co., Ltd
Study ID
NCT07733349
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • UX-DA003 — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Aug 3, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2032

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: UX-DA003

Primary Outcome Measure

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Within 6 months after administration ]

Central Contacts

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