Parkinson's DiseasePhase 1/2NCT07080775

The Safety,Tolerability, Efficacy of XS411 Cell Injection for the Treatment of Primary Parkinson's Disease

A Phase 1/2 study testing human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection in people with Parkinson's Disease, run by XellSmart Therapeutics (Shanghai) Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This Phase I clinical trial is designed to evaluate the safety, tolerability of a single dose of XS411 (derived dopaminergic neural progenitor cell injection) in patients with primary Parkinson's disease. Read more about this study

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Parkinson's Disease
What is being tested?: human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteChina
Study dates: 5 Aug 2025to Jul 2028
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 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, aged between 50 and 75 years old;
Diagnosed as 'clinically established PD' consistent with MDS clinical Diagnostic Criteria for Parkinson's disease,
A minimum of 5 years since diagnosis;
Hoehn- Yahr score during the off-time is 3 to 4;
The subjects with an average of at least 2.5 hours of "off time" per day;
Stable anti-PD therapy for at least 1 month before screening;

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Anti-PD treatment was once effective, but the efficacy has declined significantly or drug-induced motor complications have occurred, affecting the quality of life;
Positive levodopa challenge test (MDS-UPDRS-III score improvement from off- state to on- state > 30%);
At least three months before the first administration, the subject should have completed all vaccinations as recommended by local authorities;
The results of complete blood count meet the following conditions: ANC ≥ 2.0×109 /L, WBC ≥ 4.0×109 /L, PLT≥ 100×109 /L, HGB ≥ 10g/dL
The patient or his/her legal guardian agree to accept the study and signed the informed consent form in writing.

Who cannot join

Parkinsonian syndrome or secondary Parkinson's disease (Atypical Parkinson's syndrome (Parkinson's plus syndrome, secondary Parkinson's syndrome, hereditary degenerative Parkinson's syndrome);
Patients are in advanced stages of Parkinson's disease and are experiencing severe, disabling peak-dose dyskinesia or biphasic dyskinesia and/or unpredictable or widely fluctuating symptoms;
Severe cognitive impairment (MMSE<24, poor compliance due to dementia, inability to accurately record diaries, and/or inability to sign informed consent;
Those with a history of severe mental illness, or those with severe suicidal tendencies as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS), or those with suicidal ideation in the past 12 months, or those who have attempted suicide in the past 5 years;
Patients with severe brain atrophy, space-occupying lesions, hydrocephalus, cerebral vascular malformations as indicated by head CT/MRI, and those with structural abnormalities that may affect transplantation or increase surgical risks as determined by the investigators;
Currently with active internal bleeding; or arterial puncture at a site that is difficult to stop bleeding within 1 week before screening; or gastrointestinal or urinary bleeding within 3 weeks before screening;

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History of striatal or extrapyramidal surgery, including but not limited to deep brain stimulation (DBS) surgery and globus pallidus lesion;
Coagulation abnormalities;
Abnormal liver and kidney function laboratory tests during the screening period;
The patient is currently receiving or has previously received the following treatments:
Use of benzodiazepines at a dose level equal to or higher than the recommended dose in Package Insert for more than 4 weeks cumulatively since one month before enrollment, immunosuppressants (except for the immunosuppressants to be used in this study), or antipsychotics within 3 months before treatment;
Use of botulinum toxin, phenol, subarachnoid baclofen injection, or interventional treatment for dystonia or spasticity within 6 months before treatment;
Have a history of epilepsy or use anti-epileptic drugs for prevention;
Received cell therapy within 3 months before screening;
Contraindications to general anesthesia or stereotactic surgery (such as sleep apnea, chronic obstructive pulmonary disease, etc.), MRI or PET examinations;
Those with the following abnormalities in the past or detected (if any of the following is met, they will be excluded):
Evidence of congestive heart failure or history of end-stage cardiovascular disease;
Severe arrhythmias and poorly controlled arrhythmias;
Clinically significant electrocardiogram abnormalities during the screening or baseline period;
History of unstable angina or acute myocardial infarction within the past 3 months;
Diabetic patients with poor glycemic control;
Hypertensive patients with poorly controlled blood pressure;
Patients with active infection during the screening period (except mild local skin infection) that need antibiotic, antifungal, or antiviral treatment but infection is still not under control;
The presence of severe lung diseases during the screening period;
Patients with uncontrolled autoimmune diseases;
During the screening period, patients have severe arthritis, limp, severe sequelae of stroke, severe osteoporosis, or history of severe trauma within 1 month, etc., which the investigators assess may affect the evaluations;
Any history of malignancy, excluding cured basal cell carcinoma and/or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma of the breast;
Serious infectious diseases;
Pregnant or lactating women, women who plan to become pregnant during the study and within 6 months after the end of the study, or women who are unwilling to use effective contraceptive measures;
Patients who have participated in other clinical studies of drugs or medical devices within 3 months before treatment;
Have a long history of alcoholism or drug abuse;
Patients with a history of severe allergies or allergies to investigational drugs and immunosuppressants;
Any other conditions that the investigator considers unsuitable for participation in the study.
Severe depression
Hallucinations, and hallucinations still exist after optimizing Parkinson's medications
Patients have undergone MRI-guided focused ultrasound thalamotomy
Used immunosuppressants within 3 months, except for the immunosuppressants to be used in this study

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: A Phase I/II Clinical Study on the Safety, Tolerability, and Efficacy of Stereotactic Intracerebral Transplantation of Human Allogeneic iPSC-derived Dopaminergic Neuronal Precursor Cells (XS411 Cell Injection) for the Treatment of Parkinson's Disease

This Phase II clinical trial is designed to evaluate the safety, tolerability and Efficacy of XS411 (derived dopaminergic neural progenitor cell injection) in patients with Parkinson's disease.

Read the detailed description

This is a phase I clinical study to evaluate the safety and tolerability of human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection (XS411CN) via brain stereotactic transplantation for the treatment of primary Parkinson's disease.

The study adopts a single-arm, open-label, non-randomized dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of stereotactic brain transplantation of XS411CN in patients with primary Parkinson's disease and explore the optimal recommended dose. 12 to 18 patients with primary Parkinson's disease are planned to be enrolled.

On the day of cell transplantation surgery, the planned dose of XS411CN is transplanted into the bilateral putamen of the subjects by brain stereotactic technology.

After receiving the XS411CN transplantation, the subjects will receive immunosuppressants. All subjects receive standard treatment at the same time.

Each patient receives a safety observation period of 28 days after cell transplantation with XS411CN. This study adopts the traditional "3+3 " dose escalation method. The trial starts with a low dose and the dose will be increased gradually. Each subject will be closely observed for 7 days after surgery, and the dose-limiting toxicity (DLT) events that may occur within 28 days after the first transplant treatment will be evaluated.

Conditions: Parkinson's Disease
Being tested: human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injectionBiological
5.0×10^7 cells/mL, injection, single dose

Study groups in NCT07080775
Study group	Role	What they receive
4.5×10^6 cells / bilateral putamen	Experimental	Not described Receives: Biological: human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
9.0×10^6 cells / bilateral putamen	Experimental	Not described Receives: Biological: human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
1.8×10^7 cells / bilateral putamen	Experimental	Not described Receives: Biological: human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
Standard treatment	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the safety and tolerability of XS411CN in treatment of primary Parkinson's disease
To evaluate the safety and tolerability of XS411CN in treatment of primary Parkinson's disease through:
1）The occurrence and incidence of adverse events and serious adverse events (adverse event grading criteria are based on NCI-CTCAE V5.0) 28 days after administration of XS411CN; 2) Changes in vital signs, laboratory tests, 12-lead electrocardiogram, etc. compared with baseline after administration of XS411CN;
Measured: 28 days after administration of XS411CN
MDS-UPDRS Part III score during the 'OFF' state
Change from baseline in MDS-UPDRS Part III (Motor Examination) score during the 'OFF' state at 12 months after administration of XS411 cell injection
Measured: Month 12

Secondary outcomes (1)

MDS-UPDRS Part III score during the 'OFF' state
Change from baseline in MDS-UPDRS Part III (Motor Examination) score during the 'OFF' state at 3 months, 6 months, 9 months after administration of XS411 cell injection
Measured: Baseline, Month 3, Month 6, Month 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 2025Jul 2028

First posted23 Jul 2025
Study start5 Aug 2025
Primary completionJul 2027 (estimated)
Study completionJul 2028 (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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07080775
Sponsor's protocol ID: XS411-Allo-LOPD-CN1/2-P01
Status last verified: May 2026
First submitted: 9 Jul 2025
Last updated: 30 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Clinical Study on the Safety, Tolerability, and Efficacy of Stereotactic Intracerebral Transplantation of Human Allogeneic iPSC-derived Dopaminergic Neuronal Precursor Cells (XS411 Cell Injection) for the Treatment of Parkinson's Disease
ClinicalTrials.gov ID: NCT07080775
Acronym / sponsor ID: XS411-Allo-LOPD-CN1/2-P01
Conditions: Parkinson's Disease
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 39 participants (actual)
Lead sponsor: XellSmart Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Beijing Tiantan Hospital
Study start: 5 Aug 2025 (actual)
Primary completion: Jul 2027 (estimated)
Study completion: Jul 2028 (estimated)
First posted: 23 Jul 2025 (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 Phase II clinical trial is designed to evaluate the safety, tolerability and Efficacy of XS411 (derived dopaminergic neural progenitor cell injection) in patients with Parkinson's disease.

Detailed description

On the day of cell transplantation surgery, the planned dose of XS411CN is transplanted into the bilateral putamen of the subjects by brain stereotactic technology.

After receiving the XS411CN transplantation, the subjects will receive immunosuppressants. All subjects receive standard treatment at the same time.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
4.5×10^6 cells / bilateral putamen	Experimental	Biological: human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
9.0×10^6 cells / bilateral putamen	Experimental	Biological: human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
1.8×10^7 cells / bilateral putamen	Experimental	Biological: human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection
Standard treatment	No intervention	–

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male or female, aged between 50 and 75 years old;
Diagnosed as 'clinically established PD' consistent with MDS clinical Diagnostic Criteria for Parkinson's disease,
A minimum of 5 years since diagnosis;
Hoehn- Yahr score during the off-time is 3 to 4;
The subjects with an average of at least 2.5 hours of "off time" per day;

Key exclusion criteria (37 listed)

Parkinsonian syndrome or secondary Parkinson's disease (Atypical Parkinson's syndrome (Parkinson's plus syndrome, secondary Parkinson's syndrome, hereditary degenerative Parkinson's syndrome);
Patients are in advanced stages of Parkinson's disease and are experiencing severe, disabling peak-dose dyskinesia or biphasic dyskinesia and/or unpredictable or widely fluctuating symptoms;
Severe cognitive impairment (MMSE<24, poor compliance due to dementia, inability to accurately record diaries, and/or inability to sign informed consent;
Those with a history of severe mental illness, or those with severe suicidal tendencies as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS), or those with suicidal ideation in the past 12 months, or those who have attempted suicide in the past 5 years;
Patients with severe brain atrophy, space-occupying lesions, hydrocephalus, cerebral vascular malformations as indicated by head CT/MRI, and those with structural abnormalities that may affect transplantation or increase surgical risks as determined by the investigators;

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
human allogeneic induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell injection5.0×10^7 cells/mL, injection, single dose	Biological	1.8×10^7 cells / bilateral putamen, 4.5×10^6 cells / bilateral putamen, 9.0×10^6 cells / bilateral putamen

Primary outcome

To evaluate the safety and tolerability of XS411CN in treatment of primary Parkinson's disease
Time frame: 28 days after administration of XS411CN
To evaluate the safety and tolerability of XS411CN in treatment of primary Parkinson's disease through: 1）The occurrence and incidence of adverse events and serious adverse events (adverse event grading criteria are based on NCI-CTCAE V5.0) 28 days after administration of XS411CN; 2) Changes in vital signs, laboratory tests, 12-lead electrocardiogram, etc. compared with baseline after administration of XS411CN;
MDS-UPDRS Part III score during the 'OFF' state
Time frame: Month 12
Change from baseline in MDS-UPDRS Part III (Motor Examination) score during the 'OFF' state at 12 months after administration of XS411 cell injection

1 secondary outcome

MDS-UPDRS Part III score during the 'OFF' state
Time frame: Baseline, Month 3, Month 6, Month 9

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 30 Sep 2026.
Individual participant dataSharing planned: Yes

Related trials for Parkinson's Disease

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 37 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of XS411CN in treatment of primary Parkinson's disease (time frame: 28 days after administration of XS411CN). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07080775.

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 30 Sep 2026.