Parkinson DiseasePhase 1NCT06978920
A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR201 in the Treatment of Subjects With Parkinson's Disease
A Phase 1 study testing Allogeneic dopaminergic neural precursor cell(NCR201) in people with Parkinson Disease, run by Nuwacell Biotechnologies Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Allogeneic dopaminergic neural precursor cell(NCR201)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2025to 1 Dec 2028
- Phase
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 40 and 75 years;
- Diagnosed to be Parkinson's disease according to Parkinson's disease diagnostic criteria;
- Disease history over 5 years;
- Stable dose of dopamine treatment;
- Able to undergo PET/CT/MRI detection;
Who cannot join
- Patients who have previously undergone brain surgery;
- Past use of stem cell therapy or participation in stem cell clinical research;
- Cognitive impairment;
- History of mental disorders;
- Patients with other serious systemic diseases;
- Past or current metastatic malignant tumors.
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 USTC
Hefei, Anhui
The First Affiliated Hospital of USTC, 0551-96512, ahslyyxcb@163.com
About this study
Official title: A Phase I, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Dopaminergic Progenitor Cells (NCR201) Injection in the Treatment of Subjects With Parkinson's Disease
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.
Read the detailed description
Parkinson's disease (PD) is a common neurodegenerative disease in the middle-aged and elderly. It is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. Its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients' work ability and quality of life. It is estimated that nearly 100,000 people in China become new Parkinson's patients every year. Experts from the World Health Organization predict that the number of Parkinson's patients in China will reach 5 million in 2030, which will be more than half of the world's total. As the disease progresses, the symptoms of Parkinson's patients will become increasingly severe. The high prevalence and high disability rate of Parkinson's disease bring heavy burdens to individuals, families, and society.
- Conditions
- Parkinson Disease
- Being tested
- Allogeneic dopaminergic neural precursor cell(NCR201)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic dopaminergic neural precursor cell(NCR201)Drug
Bilateral implantation
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | MRI-guided bilateral stereotactic cell implantation Receives: Drug: Allogeneic dopaminergic neural precursor cell(NCR201) |
| High Dose | Experimental | MRI-guided bilateral stereotactic cell implantation Receives: Drug: Allogeneic dopaminergic neural precursor cell(NCR201) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events.
Safety and tolerability
Measured: Within 24 weeks post-transplantation
Secondary outcomes (9)
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values.
Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.
Measured: Within 24 months post-transplantation
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I,II,IV, in comparison with baseline values.
Higher scores mean a worse outcome.
Measured: Within 24 months post-transplantation
Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in Parkinson disease.
Measured: Within 24 months post-transplantation
Assessment of changes in Hamilton Depression Scale (HAMD)-17 in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in mental state.
Measured: Within 24 months post-transplantation
Assessment of changes in Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in mental state.
Measured: Within 24 months post-transplantation
Assessment of changes in Parkinson's Disease Questionnaire-39 (PDQ-39) in comparison with baseline values.
Comprehensive clinical assessment for examining the improvements in activity of daily living.
Measured: Within 24 months post-transplantation
Bilateral putamen standardized uptake value as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.
Evidence of cell survival
Measured: Within 24 months post-transplantation
Patient L-dopa equivalent dose compared with baseline.
Measure of dopaminergic drug dose
Measured: Within 24 months post-transplantation
Incidence and severity of adverse events.
Safety and tolerability
Measured: Within 24 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start6 Jun 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978920
- Sponsor's protocol ID
- NCR201-2001
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 1 Aug 2025
- 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 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Dopaminergic Progenitor Cells (NCR201) Injection in the Treatment of Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06978920
- Acronym / sponsor ID
- NCR201-2001
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 18 May 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.
The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.
Detailed description
Parkinson's disease (PD) is a common neurodegenerative disease in the middle-aged and elderly. It is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. Its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients' work ability and quality of life. It is estimated that nearly 100,000 people in China become new Parkinson's patients every year. Experts from the World Health Organization predict that the number of Parkinson's patients in China will reach 5 million in 2030, which will be more than half of the world's total. As the disease progresses, the symptoms of Parkinson's patients will become increasingly severe. The high prevalence and high disability rate of Parkinson's disease bring heavy burdens to individuals, families, and society.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: Allogeneic dopaminergic neural precursor cell(NCR201)MRI-guided bilateral stereotactic cell implantation |
| High Dose | Experimental | Drug: Allogeneic dopaminergic neural precursor cell(NCR201)MRI-guided bilateral stereotactic cell implantation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages between 40 and 75 years;
- Diagnosed to be Parkinson's disease according to Parkinson's disease diagnostic criteria;
- Disease history over 5 years;
- Stable dose of dopamine treatment;
- Able to undergo PET/CT/MRI detection;
Key exclusion criteria (6 listed)
- Patients who have previously undergone brain surgery;
- Past use of stem cell therapy or participation in stem cell clinical research;
- Cognitive impairment;
- History of mental disorders;
- Patients with other serious systemic diseases;
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 |
|---|---|---|
| Allogeneic dopaminergic neural precursor cell(NCR201)Bilateral implantation | Drug | High Dose, Low Dose |
Primary outcome
Incidence and severity of adverse events.
Time frame: Within 24 weeks post-transplantation
Safety and tolerability
9 secondary outcomes
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I,II,IV, in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Assessment of changes in Hamilton Depression Scale (HAMD)-17 in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Assessment of changes in Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Assessment of changes in Parkinson's Disease Questionnaire-39 (PDQ-39) in comparison with baseline values.
Time frame: Within 24 months post-transplantation
Bilateral putamen standardized uptake value as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.
Time frame: Within 24 months post-transplantation
Patient L-dopa equivalent dose compared with baseline.
Time frame: Within 24 months post-transplantation
Incidence and severity of adverse events.
Time frame: Within 24 months post-transplantation
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 1 Aug 2025.
- Individual participant dataSharing planned: No
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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 Phase 1 study testing Allogeneic dopaminergic neural precursor cell(NCR201) in people with Parkinson Disease, run by Nuwacell Biotechnologies 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 5 inclusion and 6 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 1 Aug 2025. 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?
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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events. (time frame: Within 24 weeks post-transplantation). 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 1 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.