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

NCT07733349 | Not Yet Recruiting Phase 1

• 1 other identifier: UX-DA003-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

allogeneic iPSC derived mDAPs; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  Within 6 months after administration

Secondary Outcomes (5)

• Changes in 18F-FP-CIT uptake detected by positron emission tomography (PET)

  Within 24 months after administration

• Changes in MDS-UPDRS scores

  Within 24 months after administration

• Changes in modified H&Y staging

  Within 24 months after administration

• Changes in daily levodopa equivalent dose (LED)

  Within 24 months after administration

• Changes in average daily 'off' and 'on' duration while awake

  Within 24 months after administration

Study Arms (1)

UX-DA003

EXPERIMENTAL

Drug: UX-DA003

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.

UX-DA003

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 30 and 75 years, regardless of gender
• Diagnosed with Parkinson's disease conforming to relevant clinical diagnostic standards with a medical history of 5-20 years
• Having received standard anti-PD treatment and been given optimal anti-PD treatment under the guidance of the investigator, but the efficacy has significantly declined
• Good response to levodopa medications, the levodopa challenge test (LCT) shows that the maximum improvement rate of the UPDRS-III score exceeds 30%
• The modified H\&Y staging (Off period) of ≥2.5 and ≤4, with total daily "off" time \>2 hours
• Stable dose of anti-Parkinson' disease drugs for at least 4 weeks prior to screening
• Good physical condition or stable concomitant diseases

You may not qualify if:

• The subjects with atypical Parkinson's syndrome or secondary Parkinson's syndrome
• Severe systemic diseases or functional impairments
• Evidence of active infection or chronic infection, which may pose a risk to the subject
• Severe concomitant central nervous system diseases or severe cognitive and psychiatric disorders
• Subjects with a history of brain injuries, cerebral vascular malformations, hydrocephalus, brain tumors, or other brain damages as shown by previous Head CT/MRI scans, or subjects with abnormal brain imaging in the striatum or other brain regions that significantly increase surgical risks
• Subjects who have participated in clinical trials for stem cell therapy or gene therapy for Parkinson's disease, or have participated in other interventional clinical trials within the last 3 months
• Subjects with a history of severe allergies or hypersensitivity reactions, known hypersensitivity to the investigational drug or its ancillary materials, or intolerance to them
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Shanghai UniXell Biotechnology Co., Ltd: lead
• Ruijin Hospital: collaborator

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Jun Liu, MD, PhD

CONTACT

+86-21-64370045; jly0520@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2032
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)