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Parkinson Disease (PD)Phase 2NCT07028632

The Safety, Feasibility and Efficacy of NouvNeu001 for Parkinson's Disease

A Phase 2 study testing Human Dopaminergic Progenitor Cells in people with Parkinson Disease (PD), run by iRegene Therapeutics Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Parkinson Disease (PD)
What is being tested?
Human Dopaminergic Progenitor Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
30 Jun 2025to Dec 2030
Phase
Phase 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

  • Age 50-75 years old, male or female
  • Able to understand the rationale of the clinical trial and sign informed consent form (ICF)
  • Diagnosis of Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease (2015)，Parkinson's disease history of ≥ 4 years
  • Medically suitable for neurosurgery under anesthesia and able to participate in Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scan
  • Hoehn-Yahr staging for "off" episodes is 2.5 to 4
  • The MDS-UPDRS Part III (MDS-UPDRS-III) score in the "off" state > 35, and positive for the Acute Levodopa Challenge Test (ALCT)
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  • Currently undergoing treatment with levodopa drugs, but with poor control of motor symptoms or reduced efficacy
  • Receive a stable dose of anti-Parkinson's disease drugs for at least 4 weeks before administration
  • Acceptable laboratory test results during screening and prior to transplantation
  • The patients agreed to postpone any other elective neurosurgery, including deep brain stimulation (DBS), until the completion of the 24-month follow-up
  • The patients agreed not to participate in any other interventional clinical studies within 24 months after administration
  • The patients agreed not to receive any vaccines within 30 days after administration

Who cannot join

  • Atypical or secondary Parkinson's syndrome to be caused by drugs, metabolic disorders or other reasons
  • The patients who have a previous history of PD-related brain surgery and have been judged by the investigator to pose significant risks or impact the assessment, or patients with contraindications for magnetic resonance imaging, or those who have been assessed by the investigator as having any contraindications for surgery or anesthesia, or patients who have received other surgeries that the investigator consider might affect their participation in this study
  • There were obvious abnormalities in the cranial CT/MRI examination
  • Those who have a history of severe cardiovascular diseases within one year prior to screening
  • Patients with a history of malignant tumors，or those who have received cellular therapy or gene therapy within the five years prior to the screening
  • Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to screening, or who cannot temporarily suspend anti-platelet agents or other anti-coagulant medications for at least 5 days before surgery
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  • Patients with long-term, heavy use of glucocorticoids or immunosuppressive drugs within 3 months prior to signing the ICF
  • Patients with a history of mental illness who are deemed unfit to participate in the study by the investigator; or a history of suicidal ideation or suicide attempts within the past year or currently
  • Patients who have used botulinum toxin within 6 months prior to signing the ICF
  • Patients with active epilepsy or currently on anti-epileptic drugs
  • Patients with a history of dementia or severe cognitive disorder, or the score of MDS-UPDRS 1.1 during screening is > 3; poor compliance, inability to accurately keep diary, and/or inability to sign ICF due to dementia
  • Patients with severe depression or with severe anxiety during screening
  • Patients with the following abnormalities during screening, including: Abnormal coagulation; Abnormal immunological tests, and assessed by the investigator it is not suitable to participate in the trial; Hypertensive patients with poorly controlled blood pressure and patients with severe postural hypotension; Diabetic patients with poorly controlled blood glucose
  • Patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD)
  • There are human immunodeficiency virus (HIV) infection, syphilis infection, and active hepatitis C virus (HCV) infection, hepatitis B virus (HBV) infection, tuberculosis infection or other active infections that the investigator consider may affect the participation of the patients in the study or affect the study outcome
  • Patients with alcohol addiction or positive for drug of abuse testing
  • Patients with a history of contraindication or allergy to the drugs used during the study or any of its components, or are allergic to the same drugs or other macrolides, or have allergies
  • Female of childbearing potential who are not surgically sterilized/premenopausal/unwilling to use medically approved effective contraception with 2 years after administration of investigational drug and lactating women; men who are not surgically sterilized/unwilling to use medically approved effective contraception with 2 years after administration of investigational drug
  • Patients who have received electric shock therapy within 30 days prior to surgery
  • Patients who are participating in other clinical trials, or have been enrolled in other clinical studies and received intervention therapy within 3 months prior to the surgery
  • Patients with severe dyskinesia in both on- and off-drug states

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Meng Cai, Ph.D contact

0086-027-59337986

caimeng@iregene.com

China1 site

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

    Haibo Chen, 01085136183, chenhbneuro@263.net

Other trials in China

About this study

Official title: A Phase I/II Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease

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.

Read the detailed description

This is a multi-center, single arm, and open label trial. The NouvNeu001 will be transplanted into bilateral putamen using stereotactic neurosurgery. Subjects will take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.

Being tested
Human Dopaminergic Progenitor Cells
Keywords
Parkinson Disease, Dopaminergic Progenitor Cells
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 Dopaminergic Progenitor CellsBiological

    Single injection of Human Dopaminergic Progenitor Cells into the putamen/striatum region of brain.

Study groups in NCT07028632
Study groupRoleWhat they receive
NouvNeu001ExperimentalNot described
Receives: Biological: Human Dopaminergic Progenitor Cells

What is being measured

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

  1. Motor Function

    Changes in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ score from baseline to 24 weeks and 48 weeks post-transplant. MDS-UPDRS Part III assesses the motor signs of PD, a higher score indicates more severe symptoms of PD.

    Measured: 24 weeks and 48 weeks post-transplant

Secondary outcomes (2)

  1. The Motor Function and Non-motor Function

    Changes in MDS-UPDRS Part I-IV Score from baseline to 48 weeks and 96 weeks post-transplant. A higher score indicates more severe symptoms or worse health.

    Measured: 48 weeks and 96 weeks post-transplant

  2. Continued Safety and Tolerability

    Incidence and severity of AEs and SAEs within 96 weeks and 5 years post-transplant.

    Measured: 96 weeks and 5 years post-transplant

Timeline

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

  1. First posted19 Jun 2025
  2. Study start30 Jun 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07028632
Sponsor's protocol ID
NouvNeu001-02-
Status last verified
Jun 2025
First submitted
11 Jun 2025
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Human Dopaminergic Progenitor Cells in people with Parkinson 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 12 inclusion and 21 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 29 Jun 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 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 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?

Motor Function (time frame: 24 weeks and 48 weeks post-transplant). 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 NCT07028632.

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 29 Jun 2025.

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