Parkinson's Disease (PD)Phase 1NCT07550374
Phase I Clinical Study of NouvNeu001 Injection for the Treatment of Moderate-to-Advanced Parkinson's Disease in Patients Who Have Previously Undergone Deep Brain Stimulation or Deep Brain Nucleus Lesioning Surgery
A Phase 1 study testing NouvNeu001 injection in people with Parkinson's Disease (PD), run by iRegene Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's Disease who have previously undergone deep brain stimulation or deep brain nucleus lesioning surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- NouvNeu001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Jul 2031
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤70 years, male or female.
- The subject understands and agrees to comply with the study procedures, voluntarily participates, and signs the informed consent form.
- Primary Parkinson's disease (meeting the diagnostic criteria of the International Parkinson and Movement Disorder Society [MDS]), and the subject has previously undergone deep brain stimulation (DBS) or deep brain nucleus lesioning surgery.
- With DBS turned off, the MDS Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination score in the "off" state is ≥30; and the levodopa challenge test is positive (improvement rate in UPDRS-III score ≥30%).
- Able to undergo neurosurgery under anesthesia, and able to undergo CT/MRI/PET examinations.
- At screening, with DBS turned on, the modified Hoehn and Yahr stage (Appendix 3) in the "off" state is between 2.5 and 4 (inclusive), and with DBS turned on, the daily "off" time is not less than 2 hours.
Show all 11Show fewer
- Has received stable doses of anti-Parkinson's disease medications for at least 4 weeks prior to administration.
- Acceptable laboratory values obtained during the screening period and prior to administration (Day 0): Absolute neutrophil count ≥ lower limit of normal (LLN); White blood cell count ≥ LLN; Platelet count ≥ LLN; AST and ALT ≤ 2.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN; eGFR ≥ 50 mL/min/1.73 m².
- The subject agrees to postpone any other elective neurosurgical procedures until completion of the 12-month follow-up study.
- The subject agrees not to participate in any other interventional clinical studies within 12 months after administration.
- The subject agrees not to receive any vaccines within 30 days after administration.
Who cannot join
- Atypical or secondary parkinsonism confirmed by the investigator to be caused by medication, metabolic disorders, or other conditions.
- Presence of persistent active infection in the previous brain surgery area, cerebrospinal fluid (CSF) leakage, or unhealed wounds; presence of implanted device malfunction, electrode displacement, etc., which in the investigator's judgment poses a significant risk to the subject or affects evaluation; contraindications to MRI (e.g., intracranial implants, cochlear implants, cardiac pacemaker/defibrillator, etc.); any contraindications to surgery or anesthesia as assessed by the investigator; or other surgical conditions that the investigator believes may affect participation in this study.
- Significant abnormalities on cranial CT/MRI, including but not limited to: cerebral vascular malformation, vasogenic edema, brain tumor, more than 10 microbleeds, basal ganglia cerebral infarction lesions, etc., which in the investigator's judgment significantly increase surgical risk.
- History of severe cardiovascular disease within 1 year prior to screening, including but not limited to: severe heart failure (New York Heart Association Class III or IV, or left ventricular ejection fraction <35% by any method), unstable angina pectoris, myocardial infarction, clinically significant conduction abnormalities (e.g., unstable atrial fibrillation), etc., which in the investigator's judgment may increase surgical risk or render the subject unsuitable for participation.
- History of malignant tumor, or receipt of cell therapy or gene therapy within 2 years prior to screening.
- Active disseminated intravascular coagulation (DIC) or significant bleeding tendency within 3 months prior to signing informed consent, or inability to discontinue antiplatelet or other anticoagulant medications for at least 5 days before surgery.
Show all 22Show fewer
- Long-term (≥14 days) and high-dose (prednisone ≥20 mg/day or equivalent dose of other glucocorticoids) use of glucocorticoids or immunosuppressants (excluding topical use) within 3 months prior to signing informed consent.
- History of psychiatric illness that, in the investigator's judgment, makes the subject unsuitable for participation; or history of suicidal ideation or suicidal attempt (including actual attempt, interrupted attempt, or aborted attempt) within the past year or currently.
- Use of botulinum toxin within 6 months prior to signing informed consent.
- Active epilepsy or current use of antiepileptic drugs at screening.
- History of dementia or severe cognitive impairment; or obvious dementia or cognitive impairment at screening; MDS-UPDRS Part 1.1 (cognitive impairment) score >3 at screening; poor compliance, inability to accurately complete diaries, and/or inability to sign informed consent due to dementia.
- Severe depression, anxiety, or severe dysphagia at screening.
- Any of the following abnormal laboratory findings at screening, including but not limited to: Clinically significant abnormalities in coagulation function (prothrombin time ≥1.5 × ULN, activated partial thromboplastin time ≥1.5 × ULN); Clinically significant immunological abnormalities or autoimmune disease, assessed by the investigator as unsuitable for trial participation; Poorly controlled hypertension (defined as blood pressure still >160/100 mmHg despite antihypertensive treatment) and severe orthostatic hypotension; Poorly controlled diabetes mellitus (HbA1c >9.0%, or fasting plasma glucose [FPG] ≥11.1 mmol/L).
- Other severe systemic diseases, such as cor pulmonale, severe chronic obstructive pulmonary disease (COPD) (FEV1% <50%), etc.
- Presence of human immunodeficiency virus (HIV) infection, syphilis infection, active hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, tuberculosis infection, or other active infections that the investigator believes may affect the subject's participation in the study or influence study outcomes.
- Alcohol dependence, or positive drug abuse screening.
- Contraindication or history of allergy to medications used during the study (e.g., tacrolimus, levodopa, etc.) or any of their components; allergy to the above drugs, other macrolide drugs; or allergic constitution (e.g., allergy to two or more drugs or foods).
- Women of childbearing age who have not undergone sterilization/are not postmenopausal/are unwilling to use medically recognized effective contraception for 2 years after study drug administration, and breastfeeding women; men who have not undergone sterilization/are unwilling to use medically recognized effective contraception for 2 years after study drug administration.
- Receipt of electroconvulsive therapy within 30 days prior to administration.
- Currently participating in another clinical trial, or having participated in another clinical study and received interventional treatment within 3 months prior to administration.
- Severe dyskinesia in both medication "on" and "off" states.
- Serious illness, or poor compliance as judged by the investigator, or any other condition that the investigator believes may jeopardize subject safety or affect study evaluation.
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
The First Affiliated Hospital of USTC
Hefei, Anhui, 230001
Chaoshi Niu, 13855086208, niuchaoshi@ustc.edu.cn
About this study
Official title: Phase I Clinical Study to Evaluate the Safety and Efficacy of NouvNeu001 Injection for the Treatment of Moderate-to-Advanced Parkinson's Disease in Patients Who Have Previously Undergone Deep Brain Stimulation or Deep Brain Nucleus Lesioning Surgery
This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's Disease who have previously undergone deep brain stimulation or deep brain nucleus lesioning surgery.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- NouvNeu001 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.
NouvNeu001 injectionBiological
NouvNeu001 injection is a Human Dopaminergic Progenitor Cell injection, administered as a single injection into the putamen/striatum region of the brain.
| Study group | Role | What they receive |
|---|---|---|
| NouvNeu001 | Experimental | Low-dose and high-dose groups are set, with 5 subjects in each dose group. All eligible subjects who are screened and successfully enrolled will receive a single administration of NouvNeu001 injection during the surgical period, delivered via stereotactic neurosurgical injection into the bilateral putamen/striatum. Receives: Biological: NouvNeu001 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Adverse Events as Assessed by CTCAE V5.0
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Measured: 48 weeks post-transplant
Secondary outcomes (7)
Changes from baseline in the MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score, as well as MDS-UPDRS Parts I, II, III (off state and on state), and IV scores at 12, 24, 36, 48, 72, and 96 weeks after administration.
Change from baseline in the MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (Part I Score 0 ~ 52 + Part II Score 0 ~ 52 + Part III Score 0 ~ 72 + Part IV Score 0 ~ 24) at Weeks 12, 24, 36, 48, 72, and 96. A higher score indicates more severe symptoms or worse health.
Measured: Weeks 12, 24, 36, 48, 72, and 96
Changes from baseline in the Modified Hoehn and Yahr Staging at 12, 24, 36, 48, 72, and 96 weeks after administration
Change from baseline in the Modified Hoehn and Yahr Staging (0, 1, 1.5, 2, 2.5, 3, 4, 5) at Weeks 12, 24, 36, 48, 72, and 96. A higher Stage indicates more severe symptoms or worse health.
Measured: Weeks 12, 24, 36, 48, 72, and 96
Changes from baseline in the Hamilton Depression Rating Scale (HAMD) score at 12, 24, 36, 48, 72, and 96 weeks after administration
Change from baseline in the Hamilton Depression Rating Scale (HAMD) score (0 ~ 53) at Weeks 12, 24, 36, 48, 72, and 96. A higher score indicates more severe symptoms or worse health.
Measured: Weeks 12, 24, 36, 48, 72, and 96
Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) score at 12, 24, 36, 48, 72, and 96 weeks after administration
Change from baseline in the Parkinson's Disease Questionnaire (PDQ-39) score (0 ~ 156) at Weeks 12, 24, 36, 48, 72, and 96. A higher score indicates more severe symptoms or worse health.
Measured: Weeks 12, 24, 36, 48, 72, and 96
Changes from baseline in "off" time and "on" time at 12, 24, 36, 48, 72, and 96 weeks after administration
Change from baseline in the "off" time and "on" time at Weeks 12, 24, 36, 48, 72, and 96. The shorter the "on" time, the longer the "off" time indicates more severe symptoms or worse health.
Measured: Weeks 12, 24, 36, 48, 72, and 96
Changes from preoperative baseline in the daily oral levodopa equivalent dose (LEDD) of patients at 12, 24, 36, 48, 72, and 96 weeks after administration
Change from baseline in the daily oral levodopa equivalent dose (LEDD) of patients at Weeks 12, 24, 36, 48, 72, and 96, A higher LEDD value indicates that the patient has used a larger dose of levodopa-class medications.
Measured: Weeks 12, 24, 36, 48, 72, and 96
Changes from baseline in Total Electrical Energy Delivered (TEED) at 12, 24, 36, 48, 72, and 96 weeks after administration
Change from baseline in Total Electrical Energy Delivered (TEED) at Weeks 12, 24, 36, 48, 72, and 96. A higher TEED value indicates that the patient has received a greater amount of electrical stimulation
Measured: Weeks 12, 24, 36, 48, 72, and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iRegene Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550374
- Sponsor's protocol ID
- NouvNeu001-05
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study to Evaluate the Safety and Efficacy of NouvNeu001 Injection for the Treatment of Moderate-to-Advanced Parkinson's Disease in Patients Who Have Previously Undergone Deep Brain Stimulation or Deep Brain Nucleus Lesioning Surgery
- ClinicalTrials.gov ID
- NCT07550374
- Acronym / sponsor ID
- NouvNeu001-05
- Conditions
- Parkinson's Disease (PD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- iRegene Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 24 Apr 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 trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's Disease who have previously undergone deep brain stimulation or deep brain nucleus lesioning surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NouvNeu001 | Experimental | Biological: NouvNeu001 injectionLow-dose and high-dose groups are set, with 5 subjects in each dose group. All eligible subjects who are screened and successfully enrolled will receive a single administration of NouvNeu001 injection during the surgical period, delivered via stereotactic neurosurgical injection into the bilateral putamen/striatum. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years and ≤70 years, male or female.
- The subject understands and agrees to comply with the study procedures, voluntarily participates, and signs the informed consent form.
- Primary Parkinson's disease (meeting the diagnostic criteria of the International Parkinson and Movement Disorder Society [MDS]), and the subject has previously undergone deep brain stimulation (DBS) or deep brain nucleus lesioning surgery.
- With DBS turned off, the MDS Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination score in the "off" state is ≥30; and the levodopa challenge test is positive (improvement rate in UPDRS-III score ≥30%).
- Able to undergo neurosurgery under anesthesia, and able to undergo CT/MRI/PET examinations.
Key exclusion criteria (22 listed)
- Atypical or secondary parkinsonism confirmed by the investigator to be caused by medication, metabolic disorders, or other conditions.
- Presence of persistent active infection in the previous brain surgery area, cerebrospinal fluid (CSF) leakage, or unhealed wounds; presence of implanted device malfunction, electrode displacement, etc., which in the investigator's judgment poses a significant risk to the subject or affects evaluation; contraindications to MRI (e.g., intracranial implants, cochlear implants, cardiac pacemaker/defibrillator, etc.); any contraindications to surgery or anesthesia as assessed by the investigator; or other surgical conditions that the investigator believes may affect participation in this study.
- Significant abnormalities on cranial CT/MRI, including but not limited to: cerebral vascular malformation, vasogenic edema, brain tumor, more than 10 microbleeds, basal ganglia cerebral infarction lesions, etc., which in the investigator's judgment significantly increase surgical risk.
- History of severe cardiovascular disease within 1 year prior to screening, including but not limited to: severe heart failure (New York Heart Association Class III or IV, or left ventricular ejection fraction <35% by any method), unstable angina pectoris, myocardial infarction, clinically significant conduction abnormalities (e.g., unstable atrial fibrillation), etc., which in the investigator's judgment may increase surgical risk or render the subject unsuitable for participation.
- History of malignant tumor, or receipt of cell therapy or gene therapy within 2 years prior to screening.
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 |
|---|---|---|
| NouvNeu001 injectionNouvNeu001 injection is a Human Dopaminergic Progenitor Cell injection, administered as a single injection into the putamen/striatum region of the brain. | Biological | NouvNeu001 |
Primary outcome
Incidence and severity of Adverse Events as Assessed by CTCAE V5.0
Time frame: 48 weeks post-transplant
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
7 secondary outcomes
Changes from baseline in the MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score, as well as MDS-UPDRS Parts I, II, III (off state and on state), and IV scores at 12, 24, 36, 48, 72, and 96 weeks after administration.
Time frame: Weeks 12, 24, 36, 48, 72, and 96
Changes from baseline in the Modified Hoehn and Yahr Staging at 12, 24, 36, 48, 72, and 96 weeks after administration
Time frame: Weeks 12, 24, 36, 48, 72, and 96
Changes from baseline in the Hamilton Depression Rating Scale (HAMD) score at 12, 24, 36, 48, 72, and 96 weeks after administration
Time frame: Weeks 12, 24, 36, 48, 72, and 96
Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) score at 12, 24, 36, 48, 72, and 96 weeks after administration
Time frame: Weeks 12, 24, 36, 48, 72, and 96
Changes from baseline in "off" time and "on" time at 12, 24, 36, 48, 72, and 96 weeks after administration
Time frame: Weeks 12, 24, 36, 48, 72, and 96
Changes from preoperative baseline in the daily oral levodopa equivalent dose (LEDD) of patients at 12, 24, 36, 48, 72, and 96 weeks after administration
Time frame: Weeks 12, 24, 36, 48, 72, and 96
Changes from baseline in Total Electrical Energy Delivered (TEED) at 12, 24, 36, 48, 72, and 96 weeks after administration
Time frame: Weeks 12, 24, 36, 48, 72, and 96
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 24 Apr 2026.
Related trials for Parkinson's Disease (PD)
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
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)
RecruitingObservational study
Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation
Parkinson Disease
Not yet recruiting
Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.
Parkinson Disease
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 NouvNeu001 injection in people with Parkinson's Disease (PD), run by iRegene Therapeutics 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 11 inclusion and 22 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: opening soon, as of the sponsor's last update on 24 Apr 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?
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?
Contact Meng Cai, Ph.D (0086-027-59337986, caimeng@iregene.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 as Assessed by CTCAE V5.0 (time frame: 48 weeks post-transplant). 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 24 Apr 2026.