NouvNeu001 for Parkinson's Disease

(NouvNeu001-01 Trial)

Overseen By Meng Cai, Ph.D

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: iRegene Therapeutics Co., Ltd.

Must be taking: Dopamine drugs

Must not be taking: Antipsychotics, Immunosuppressants

Disqualifiers: Atypical Parkinsonism, Dementia, Severe heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24-36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NouvNeu001 to determine its safety and effectiveness for people with advanced Parkinson's Disease. The treatment involves a single injection of special cells into specific parts of the brain, aiming to manage symptoms and improve quality of life. Individuals who have had Parkinson's for 4 to 20 years and experience frequent movement issues might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial requires that you have been on a stable dose of your Parkinson's medication for at least 4 weeks before starting the study drug. However, you may need to stop certain medications like anti-platelet agents or anti-coagulants at least 5 days before surgery. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that NouvNeu001 is likely to be safe for humans?

Research shows that NouvNeu001, a treatment using special cells, is being tested for safety in people with Parkinson's Disease. An earlier study found this treatment safe for patients. Although testing is still in its early stages, some reports suggest improvements in movement with NouvNeu001, indicating a positive effect. However, as this is a Phase 1 study, the primary focus is ensuring the treatment's safety for people. So far, no detailed reports of serious side effects have emerged, which is encouraging. However, more research is needed to confirm these results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Parkinson's Disease, which typically involve medications like Levodopa and Dopamine Agonists to manage symptoms, NouvNeu001 uses a groundbreaking approach by injecting Human Dopaminergic Progenitor Cells directly into specific brain regions. This method aims to restore dopamine production by replacing the damaged neurons rather than just alleviating symptoms. Researchers are excited about this treatment because it has the potential to address the root cause of Parkinson's, offering hope for more sustained and effective relief.

What evidence suggests that NouvNeu001 might be an effective treatment for Parkinson's Disease?

Research has shown that NouvNeu001 may help treat advanced Parkinson's Disease. Early results suggest that patients receiving this treatment in the trial have experienced improvements in movement and coordination. NouvNeu001 works by transplanting special brain cells into specific brain areas to restore dopamine levels, a chemical often low in people with Parkinson's. Early data indicated significant improvements in movement after the transplant. This new approach aims to address the root cause of the disease, offering hope for better symptom management. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced Parkinson's Disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a particular stage or severity of the disease.

Inclusion Criteria

I am between 30 and 75 years old.

My Parkinson's disease is advanced, and I respond well to levodopa.

I agree not to get the COVID-19 vaccine 14 days before or any vaccine 30 days after my brain surgery.

Exclusion Criteria

I have not used immunosuppressive drugs for more than 14 days in the last 3 months.

I have had brain issues like trauma or tumors noted in previous scans.

I am willing to use effective contraception during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of Human Dopaminergic Progenitor Cells into the bilateral putamen/striatum regions of the brain and take immunosuppressants to prevent potential immune rejection

24-36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of motor and non-motor function changes

96 weeks

Long-term follow-up

Continued monitoring of safety and tolerability, including incidence and severity of adverse events

15 years

What Are the Treatments Tested in This Trial?

Interventions

• NouvNeu001

Trial Overview The study is testing NouvNeu001, which consists of human dopaminergic progenitor cells injected into patients. It's in phase 1, focusing on assessing how safe and tolerable this treatment is and if it shows signs of effectiveness.

How Is the Trial Designed?

Group I: NouvNeu001 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

iRegene Therapeutics Co., Ltd.

Lead Sponsor

Trials

4

Recruited

180+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06167681

Study Details | NCT06167681 | The Safety, Tolerability and ... This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor ...

2. biospace.com biospace.com/press-releases/iregene-therapeutics-announced-promising-nouvneu001-phase-i-clinical-data

iRegene Therapeutics announced promising NouvNeu001 ... Recently, NouvNeu001 Phase I clinical data were presented at the International Congress of Parkinson's Disease and Movement Disorders (MDS).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07102342

Study Details | NCT07102342 | This ... This is a phase 1 clinical study to evaluate the safety, tolerability, feasibility, and preliminary efficacy of NouvNeu001 in patients with ...

4. mdsabstracts.org mdsabstracts.org/abstract/nouvneu001-a-phase-1-stage-chemically-induced-human-dopaminergic-progenitor-cell-therapy-for-the-treatment-of-mid-to-late-stage-parkinsons-disease/

NouvNeu001, A Phase 1 Stage Chemically Induced ... Efficacy and safety were evaluated post transplantation of NouvNeu001. Results: NouvNeu001 transplantation leads to significant improvement in motor function ...

5. practicalneurology.com practicalneurology.com/news/novel-cell-therapy-cleared-by-fda-for-investigation-as-potential-treatment-for-parkinson-disease/2470517/

Novel Cell Therapy Cleared by FDA for Investigation as ... According to iRegene's statement, preliminary results suggest that people receiving treatment with NouvNeu001 demonstrated improvements in motor ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07028632

The Safety, Feasibility and Efficacy of NouvNeu001 for ... This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06167681/the-safety-tolerability-and-efficacy-of-nouvneu001-for-parkinsons-disease

The Safety, Tolerability and Efficacy of NouvNeu001 for ... This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic ...