Human Dopaminergic Progenitor Cells for Parkinson's (NCT06167681)
Replace lost movement brain cells
- 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 movement brain cells
- 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
The goal is to see if a single injection of specialized human cells can be given safely, tolerated well, and show early benefit for people with mid- to late-stage Parkinson's disease. The plan is to place these cells, which are intended to become dopamine-making brain cells, into both sides of the movement-control part of the brain using precise, image-guided surgery, and participants will take medicines that suppress the immune system for about 24 to 36 weeks to reduce the risk of rejection. The study seeks men and women aged 50 to 75 who have had Parkinson's for 4 to 20 years, are at a mid- to late-stage of the disease, and are medically able to undergo brain surgery and scans, with several exclusion rules for other brain or medical conditions and prior related surgeries.
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. The goal is to see if a single injection of specialized human cells can be given safely, tolerated well, and show early benefit for people with mid- to late-stage Parkinson's disease. The plan is to place these cells, which are intended to become dopamine-making brain cells, into both sides of the movement-control part of the brain using precise, image-guided surgery, and participants will take medicines that suppress the immune system for about 24 to 36 weeks to reduce the risk of rejection. The study seeks men and women aged 50 to 75 who have had Parkinson's for 4 to 20 years, are at a mid- to late-stage of the disease, and are medically able to undergo brain surgery and scans, with several exclusion rules for other brain or medical conditions and prior related surgeries.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1/Phase 2 trial is estimated to last approximately 1 year and 10 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Injection (minimally invasive). Confirm the full schedule with the study coordinator.