PARKINSON DISEASE (Disorder)Early Phase 1NCT07911670
Exploratory Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
A Early Phase 1 study testing UX-DA003 in people with PARKINSON DISEASE (Disorder), run by The First Affiliated Hospital of Anhui Medical University 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 DISEASE (Disorder)
- 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
- 23 Nov 2026to Jun 2032
- Phase
- Early Phase 1
- 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
The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui
Jinmei Sun, MD, +86 0551 62923704, sunjinmei0628@163.com
About this study
Official title: Exploratory Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of UX-DA003 Injection (Human iPSC-derived Midbrain Dopaminergic Neural Precursor Cells) 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 a single-arm, open-label, dose-escalation exploratory clinical trial aimed at evaluating the safety, tolerability, and preliminary efficacy of different doses of UX-DA003 injections for treating patients with Parkinson's disease. Eligible participants are mid-to-late stage PD patients who have shown significant decline in response after standard PD treatment and have not undergone DBS surgery.
The study planned two dose groups: a low-dose group receiving 3.6×10^6 cells per side (6 patients) and a high-dose group receiving 5.4×10^6 cells per side (6 patients). A total of 12 patients are planned to be enrolled, with each patient receiving only one dose of UX-DA003 for bilateral putamen cell transplantation.
A Safety Monitoring Committee (SMC) has been set up for the study, which can decide based on safety data whether to include additional patients after the sentinel cases, start enrollment in the next dose group, explore other dose levels, increase the number of patients in any dose group, or stop/modify the trial protocol.
Enrollment for each dose group proceeds from low to high. Each dose group includes sentinel cases, where the first patient is monitored for 4 weeks after cell transplantation. Only after the SMC reviews the safety data can subsequent patients receive cell transplantation.
Four weeks after the last patient in each dose group receives transplantation, the SMC will conduct an overall safety assessment for all patients and discuss the next steps.
The trial visit schedule includes a screening period (D-30 to D-15), baseline period (D-14 to D-1), surgery and post-op observation period (D0 to D28), follow-up period (M3 to M24), and long-term follow-up period (Y3 to Y5). Screening and baseline periods involve screening checks, baseline assessment, and pre-op examinations. Surgery takes place on D0, with hospitalization required the day before (D-1) and on post-op day 4. Patients return to the hospital on day 14 (D14) and day 28 (D28) for follow-up. Follow-up visits occur at 3, 6, 9, 12, 18, and 24 months to assess safety and efficacy. Patients completing the 24-month follow-up enter the long-term follow-up period, with annual visits up to 5 years post-surgery.
During the trial, patients are allowed to continue using regular anti-Parkinson medications at a stable dose to manage PD symptoms.
- Conditions
- PARKINSON DISEASE (Disorder)
- 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 (6)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: Within 24 months after administration
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 posted3 Nov 2026
- Study start23 Nov 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai UniXell Biotechnology Co., Ltd
- Responsible party
- Principal investigator, Panpan Hu, MD, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911670
- Sponsor's protocol ID
- UX-DA003-102
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of UX-DA003 Injection (Human iPSC-derived Midbrain Dopaminergic Neural Precursor Cells) in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07911670
- Acronym / sponsor ID
- UX-DA003-102
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- allogeneic iPSC derived mDAPs, Parkinson's Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai UniXell Biotechnology Co., Ltd
- Study start
- 23 Nov 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 3 Nov 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 a single-arm, open-label, dose-escalation exploratory clinical trial aimed at evaluating the safety, tolerability, and preliminary efficacy of different doses of UX-DA003 injections for treating patients with Parkinson's disease. Eligible participants are mid-to-late stage PD patients who have shown significant decline in response after standard PD treatment and have not undergone DBS surgery.
The study planned two dose groups: a low-dose group receiving 3.6×10^6 cells per side (6 patients) and a high-dose group receiving 5.4×10^6 cells per side (6 patients). A total of 12 patients are planned to be enrolled, with each patient receiving only one dose of UX-DA003 for bilateral putamen cell transplantation.
A Safety Monitoring Committee (SMC) has been set up for the study, which can decide based on safety data whether to include additional patients after the sentinel cases, start enrollment in the next dose group, explore other dose levels, increase the number of patients in any dose group, or stop/modify the trial protocol.
Enrollment for each dose group proceeds from low to high. Each dose group includes sentinel cases, where the first patient is monitored for 4 weeks after cell transplantation. Only after the SMC reviews the safety data can subsequent patients receive cell transplantation.
Four weeks after the last patient in each dose group receives transplantation, the SMC will conduct an overall safety assessment for all patients and discuss the next steps.
The trial visit schedule includes a screening period (D-30 to D-15), baseline period (D-14 to D-1), surgery and post-op observation period (D0 to D28), follow-up period (M3 to M24), and long-term follow-up period (Y3 to Y5). Screening and baseline periods involve screening checks, baseline assessment, and pre-op examinations. Surgery takes place on D0, with hospitalization required the day before (D-1) and on post-op day 4. Patients return to the hospital on day 14 (D14) and day 28 (D28) for follow-up. Follow-up visits occur at 3, 6, 9, 12, 18, and 24 months to assess safety and efficacy. Patients completing the 24-month follow-up enter the long-term follow-up period, with annual visits up to 5 years post-surgery.
During the trial, patients are allowed to continue using regular anti-Parkinson medications at a stable dose to manage PD symptoms.
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
6 secondary outcomes
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Within 24 months after administration
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 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing UX-DA003 in people with PARKINSON DISEASE (Disorder), run by The First Affiliated Hospital of Anhui Medical University 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 3 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jinmei Sun, MD (+86 0551 62923704, sunjinmei0628@163.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 3 Nov 2026.