NCT06778265

An Exploratory Clinical Study of UX-DA001 in Subjects With Idiopathic Parkinson's Disease

An Exploratory Clinical Study to Evaluate UX-DA001 Injection (Human Midbrain Dopaminergic Progenitor Cells Injection) in Subjects With Idiopathic Parkinson's Disease

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai UniXell Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is an open-label, multi-center, dose-escalation and dose-expansion exploratory clinical study to evaluate the safety, tolerability, and potential efficacy of UX-DA001 Injection at different dose levels implanted in subjects with idiopathic PD. Each subject receives only one dose of UX-DA001 for implantation into the putamen bilaterally using stereotactic neurosurgery under general anesthesia. Safety and tolerability of UX-DA001 and its effect on Parkinson's disease symptoms are assessed for 2 years post-treatment.

Conditions

• Parkinson Disease, Idiopathic

Interventions

Type	Name	Description
BIOLOGICAL	UX-DA001	UX-DA001 (Human Midbrain Dopaminergic Progenitor Cells) is used for treating patients with iPD via implanting into bilateral putamina under stereotactic neurosurgery. Two dose levels will be planned. Each patient only receives one corresponding dose of UX-DA001.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-01-16
• Last updated: 2026-01-12

Locations

1 site across 1 country: China