Parkinson's DiseasePhase 1/2NCT07733349
Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
A Phase 1/2 study testing UX-DA003 in people with Parkinson's Disease, run by Shanghai UniXell Biotechnology Co., Ltd at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- UX-DA003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2026to 31 Aug 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Jun Liu, MD, PhD, +86-21-64370045, jly0520@hotmail.com
Jun Liu, MD, PhD
About this study
Official title: Phase I/II Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of UX-DA003 Injection in Patients With Parkinson's Disease
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.
- Conditions
- Parkinson's Disease
- Being tested
- UX-DA003
- Keywords
- allogeneic iPSC derived mDAPs, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UX-DA003Drug
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 group | Role | What they receive |
|---|---|---|
| UX-DA003 | Experimental | Not described Receives: Drug: UX-DA003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: Within 6 months after administration
Secondary outcomes (5)
Changes in 18F-FP-CIT uptake detected by positron emission tomography (PET)
Measured: Within 24 months after administration
Changes in MDS-UPDRS scores
Measured: Within 24 months after administration
Changes in modified H&Y staging
Measured: Within 24 months after administration
Changes in daily levodopa equivalent dose (LED)
Measured: Within 24 months after administration
Changes in average daily 'off' and 'on' duration while awake
Measured: Within 24 months after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start24 Sep 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai UniXell Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733349
- Sponsor's protocol ID
- UX-DA003-101
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of UX-DA003 Injection in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07733349
- Acronym / sponsor ID
- UX-DA003-101
- Conditions
- Parkinson's Disease
- Keywords
- allogeneic iPSC derived mDAPs, Parkinson's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai UniXell Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital
- Study start
- 24 Sep 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UX-DA003 | Experimental | Drug: UX-DA003 |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UX-DA003UX-DA003 (Human Allogeneic iPSC-derived Midbrain Dopaminergic Progenitor cells) is used for treating patients with PD via implanting into bilateral putamina under stereotactic neurosurgery. | Drug | UX-DA003 |
Primary outcome
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Within 6 months after administration
5 secondary outcomes
Changes in 18F-FP-CIT uptake detected by positron emission tomography (PET)
Time frame: Within 24 months after administration
Changes in MDS-UPDRS scores
Time frame: Within 24 months after administration
Changes in modified H&Y staging
Time frame: Within 24 months after administration
Changes in daily levodopa equivalent dose (LED)
Time frame: Within 24 months after administration
Changes in average daily 'off' and 'on' duration while awake
Time frame: Within 24 months after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UX-DA003 in people with Parkinson's Disease, run by Shanghai UniXell Biotechnology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Liu, MD, PhD (+86-21-64370045, jly0520@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (time frame: Within 6 months after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.