Replace lost dopamine producing neurons
- Trial ID
- NCT06167681
- 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
- Goal
- Replace lost dopamine producing neurons
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- iRegene Therapeutics Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson Disease
- Interventions
- Human Dopaminergic Progenitor Cells
Summary For Families
It aims to replace lost dopamine-producing neurons to ease the severe motor problems and disability that happen in mid- to late-stage Parkinson's. Doctors inject human dopaminergic progenitor cells into the brain so the cells can mature into dopamine neurons that make dopamine locally, potentially reducing symptoms and future dependence on levodopa while initially being used alongside existing meds. Looking for people aged 50 to 75, diagnosed 4 to 20 years ago, who are mid-to-late stage (Hoehn‑Yahr 2.5,4 when off), have a strong levodopa response and an MDS‑UPDRS‑III off score over 35, and who are medically fit for brain surgery and imaging, with common exclusions like prior DBS or cell therapy, active serious infections, uncontrolled medical or psychiatric conditions, or ongoing infusion/apomorphine treatments.
Locations
- Beijing Hospital, Beijing, Beijing Municipality, China
- Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Human Dopaminergic Progenitor Cells. It aims to replace lost dopamine-producing neurons to ease the severe motor problems and disability that happen in mid- to late-stage Parkinson's. Doctors inject human dopaminergic progenitor cells into the brain so the cells can mature into dopamine neurons that make dopamine locally, potentially reducing symptoms and future dependence on levodopa while initially being used alongside existing meds. Looking for people aged 50 to 75, diagnosed 4 to 20 years ago, who are mid-to-late stage (Hoehn‑Yahr 2.5,4 when off), have a strong levodopa response and an MDS‑UPDRS‑III off score over 35, and who are medically fit for brain surgery and imaging, with common exclusions like prior DBS or cell therapy, active serious infections, uncontrolled medical or psychiatric conditions, or ongoing infusion/apomorphine treatments.
- Who can participate?
- Participants must be between 50 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1/Phase 2 trial is estimated to last approximately 1 year and 10 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.