Human Dopaminergic Progenitor Cells for Parkinson's (NCT06608355)
Test cell transplant for movement
- 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
- Test cell transplant for movement
- 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 learn whether NouvNeu001 injections are safe for people with early-onset Parkinson's and whether the treatment changes motor symptoms and other non-movement symptoms, while tracking any medical problems that happen when the cells are placed into both sides of the putamen. Participants will have NouvNeu001, a transplant of human cells, injected into both sides of that brain area using stereotactic neurosurgery, and will take medicines that suppress the immune system for 24 to 36 weeks to reduce the chance of rejection. The study seeks adults 18 to 70 whose Parkinson's began at age 50 or younger, who are medically fit for brain surgery and imaging, who meet specific movement-severity tests while off medication, and who respond to a short levodopa challenge.
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 learn whether NouvNeu001 injections are safe for people with early-onset Parkinson's and whether the treatment changes motor symptoms and other non-movement symptoms, while tracking any medical problems that happen when the cells are placed into both sides of the putamen. Participants will have NouvNeu001, a transplant of human cells, injected into both sides of that brain area using stereotactic neurosurgery, and will take medicines that suppress the immune system for 24 to 36 weeks to reduce the chance of rejection. The study seeks adults 18 to 70 whose Parkinson's began at age 50 or younger, who are medically fit for brain surgery and imaging, who meet specific movement-severity tests while off medication, and who respond to a short levodopa challenge.
- 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?
- 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 trial is estimated to last approximately 1 year and 7 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.