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Parkinson DiseasePhase 1/2NCT06167681

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

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

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

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
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
40 participants
Where
2 sitesChina
Study dates
17 Jan 2024to Jul 2029
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

  • 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)
  • Diagnosis of Parkinson's Disease made between 4 to 20 years ago
  • Medically suitable for neurosurgery under anesthesia and able to participate in 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)
  • Acceptable laboratory test results during screening and prior to transplantation

Who cannot join

  • Atypical Parkinsonism
  • Patients who have had previous pallidotomy, deep brain stimulation (DBS) surgery, striatal or extrapyramidal surgery, brain stereotaxy or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's participation in this study
  • Patients who have a previous head CT/MRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery.
  • Patients with a history of severe cardiovascular and cerebrovascular diseases
  • Patients with a history of malignant tumors
  • Patients who have had previous cellular therapy
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  • 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
  • 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 surgical contraindications, or with other surgical procedures within 6 months before screening which, in the opinion of the investigator, have an impact on this trial; Patients with other neurosurgical contraindications
  • Patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD)
  • Presence of one of the following: positive for human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody and HCV RNA; Hepatitis B virus (HBV) surface antigen positive and HBV DNA copy number > detection of normal values; Tuberculosis is in the active stage; Other active infections that the investigator believes may affect Patients' participation in the study or affect study outcomes;
  • 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 poor compliance based on clinical evaluation of the investigator
  • Patients who are being treated with drugs such as apomorphine, or levodopa/carbidopa infusion therapy
  • Patients with severe dyskinesia in both on- and off-drug states

Trial locations and contacts

2 sites 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

China2 sites, 2 recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

    Haibo Chen, chenhbneuro@263.net

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Nanxiang Xiong, mozhuoxiong@163.com

    Not yet recruiting

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/striatum 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 NCT06167681
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. Safety and Tolerability

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

    Measured: 24 weeks and 48 weeks post-transplant

  2. Motor Function

    Changes in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ score from baseline to 24 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 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 posted12 Dec 2023
  2. Study start17 Jan 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionJul 2029 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06167681
Sponsor's protocol ID
NouvNeu001-02
Status last verified
Jul 2024
First submitted
24 Nov 2023
Last updated
1 Nov 2024
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 1/2 study testing Human Dopaminergic Progenitor Cells in people with Parkinson Disease, run by iRegene Therapeutics Co., Ltd. at 2 sites 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 8 inclusion and 25 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 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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?

Safety and Tolerability (time frame: 24 weeks and 48 weeks post-transplant). 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 NCT06167681.

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 Nov 2024.

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