Early-onset Parkinson's DiseasePhase 1NCT06608355
The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's Disease
A Phase 1 study testing Human Dopaminergic Progenitor Cells in people with Early-onset Parkinson's Disease, run by iRegene Therapeutics Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Early-onset Parkinson's 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
- 6 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2024to Mar 2027
- 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 18-70 years old, male or female
- Able to understand the rationale of the clinical trial and sign informed consent form (ICF)
- Diagnosis of Early-onset Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease, and the age of onset was ≤50 years old
- Medically suitable for neurosurgery under anesthesia and able to participate in Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) scan.
- Hoehn-Yahr staging for "off" episodes is 2 to 4
- The MDS-UPDRS-III score in the "off" state >30, 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, striatal or extrapyramidal surgery 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 with surgical contraindications or other neurosurgical contraindications
- 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 received stem cell therapy for Parkinson's disease within 2 years before signing the ICF
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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
- 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)
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College Hust
Wuhan, Hubei, 430030
Wei Wang, 027-83663337, wwang@vip.126.com
Xiang Luo, 027-83663337, flydottjh@163.com
About this study
Official title: A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of NouvNeu001 Injection in the Treatment of Early-onset Parkinson's Disease
The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment. The main questions it aims to answer are:
What medical problems do participants have when transplanting NouvNeu001 into bilateral putamen using stereotactic neurosurgery? Does injection of NouvNeu001 improve the motor function and non-motor function in participants?
Participants will:
Be injectioned the NouvNeu001 into bilateral putamen using stereotactic neurosurgery.
Take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.
- Conditions
- Early-onset Parkinson's Disease
- Being tested
- Human Dopaminergic Progenitor Cells
- Keywords
- Early-onset Parkinson's Disease, Dopaminergic Progenitor Cells
- Medical subject headings
- Parkinsonian Disorders
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 of brain.
| Study group | Role | What they receive |
|---|---|---|
| NouvNeu001 | Experimental | Not described Receives: Biological: Human Dopaminergic Progenitor Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Measured: Enrollment to 96 weeks post-transplant.
Secondary outcomes (1)
The Motor Function and Non-motor Function
Changes in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I-IV Score from baseline. A higher score indicates more severe symptoms or worse health.
Measured: Baseline to 48 weeks and 96 weeks post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start23 Aug 2024
- Primary completionApr 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-onset 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT06608355
- Sponsor's protocol ID
- NouvNeu001-03
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 7 Nov 2024
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of NouvNeu001 Injection in the Treatment of Early-onset Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06608355
- Acronym / sponsor ID
- NouvNeu001-03
- Conditions
- Early-onset Parkinson's Disease
- Keywords
- Early-onset Parkinson's Disease, Dopaminergic Progenitor Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- iRegene Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Sep 2024 (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 learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment. The main questions it aims to answer are:
What medical problems do participants have when transplanting NouvNeu001 into bilateral putamen using stereotactic neurosurgery? Does injection of NouvNeu001 improve the motor function and non-motor function in participants?
Participants will:
Be injectioned the NouvNeu001 into bilateral putamen using stereotactic neurosurgery.
Take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.
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: Human Dopaminergic Progenitor Cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-70 years old, male or female
- Able to understand the rationale of the clinical trial and sign informed consent form (ICF)
- Diagnosis of Early-onset Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease, and the age of onset was ≤50 years old
- Medically suitable for neurosurgery under anesthesia and able to participate in Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) scan.
- Hoehn-Yahr staging for "off" episodes is 2 to 4
Key exclusion criteria (24 listed)
- Atypical Parkinsonism
- Patients who have had previous pallidotomy, striatal or extrapyramidal surgery 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 with surgical contraindications or other neurosurgical contraindications
- 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
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 Dopaminergic Progenitor CellsSingle injection of Human Dopaminergic Progenitor Cells into the putamen of brain. | Biological | NouvNeu001 |
Primary outcome
Safety and Tolerability
Time frame: Enrollment to 96 weeks post-transplant.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
1 secondary outcome
The Motor Function and Non-motor Function
Time frame: Baseline to 48 weeks and 96 weeks post-transplant
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 7 Nov 2024.
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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 Human Dopaminergic Progenitor Cells in people with Early-onset Parkinson's Disease, 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 7 inclusion and 24 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 7 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 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 (86-027-59338180, 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: Enrollment to 96 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 7 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.