Replace lost dopamine producing neurons
- Trial ID
- NCT06608355
- 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
- Goal
- Replace lost dopamine producing neurons
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- iRegene Therapeutics Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Early-onset Parkinson's Disease
- Interventions
- Human Dopaminergic Progenitor Cells
Summary For Families
The goal is to see if a one-time neurosurgical transplantation of human dopaminergic progenitor cells can safely replace lost dopamine-producing cells and improve motor symptoms in people with early-onset Parkinson's, while monitoring for side effects and any early signs of benefit. The approach injects lab-grown dopaminergic precursor cells into the brain so they can mature into dopamine neurons and release dopamine, potentially smoothing movement problems and lowering dependence on levodopa; participants must show they respond to levodopa on an acute challenge. Eligible volunteers are adults 18 to 70 whose Parkinson's began at age 50 or younger, who are Hoehn-Yahr stage 2 to 4 off medication, have MDS-UPDRS-III scores over 30 off meds, and are medically fit for brain surgery. People with atypical parkinsonism, prior certain brain surgeries, active infections or serious medical or psychiatric conditions, recent stem-cell or infusion therapies, or who cannot commit to two years of contraception after treatment are excluded.
Locations
- Tongji Hospital Affiliated to Tongji Medical College Hust, Wuhan, Hubei, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Human Dopaminergic Progenitor Cells. The goal is to see if a one-time neurosurgical transplantation of human dopaminergic progenitor cells can safely replace lost dopamine-producing cells and improve motor symptoms in people with early-onset Parkinson's, while monitoring for side effects and any early signs of benefit. The approach injects lab-grown dopaminergic precursor cells into the brain so they can mature into dopamine neurons and release dopamine, potentially smoothing movement problems and lowering dependence on levodopa; participants must show they respond to levodopa on an acute challenge. Eligible volunteers are adults 18 to 70 whose Parkinson's began at age 50 or younger, who are Hoehn-Yahr stage 2 to 4 off medication, have MDS-UPDRS-III scores over 30 off meds, and are medically fit for brain surgery. People with atypical parkinsonism, prior certain brain surgeries, active infections or serious medical or psychiatric conditions, recent stem-cell or infusion therapies, or who cannot commit to two years of contraception after treatment are excluded.
- Who can participate?
- Participants must be between 18 Years and 70 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 trial is estimated to last approximately 1 year and 7 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.