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Not yet recruitingNCT07733349Updated Jul 29, 2026

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

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

Phase
Phase 1/2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Parkinson's Disease

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Keywords

  • allogeneic iPSC derived mDAPs
  • Parkinson's Disease
03

In context

Parkinson Disease

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    UX-DA003

    Drug: UX-DA003

Interventions

  • DrugUX-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.

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Within 6 months after administration

Secondary outcomes

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

    Time frame: Within 24 months after administration

  2. Changes in MDS-UPDRS scores

    Time frame: Within 24 months after administration

  3. Changes in modified H&Y staging

    Time frame: Within 24 months after administration

  4. Changes in daily levodopa equivalent dose (LED)

    Time frame: Within 24 months after administration

  5. Changes in average daily 'off' and 'on' duration while awake

    Time frame: Within 24 months after administration

07

Study locations

1 site
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, 200025, China
    • Jun Liu, MD, PhD · Contact · jly0520@hotmail.com · +86-21-64370045
    • Jun Liu, MD, PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07733349
Lead sponsor
Shanghai UniXell Biotechnology Co., Ltd
Collaborators
Ruijin Hospital
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Aug 3, 2026 (estimated)
Primary completion
Aug 31, 2029 (estimated)
Completion
Aug 31, 2032 (estimated)
Last update
Jul 29, 2026

Study contacts

Jun Liu, MD, PhD
Contact
jly0520@hotmail.com
+86-21-64370045

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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