Human Dopaminergic Progenitor Cells for Parkinson's (NCT07102342)
Transplant cells to improve movement
- Trial ID
- NCT07102342
- Official Title
- A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Feasibility, and Preliminary Efficacy of NouvNeu001 in Patients With Advanced Parkinson's Disease.
- Goal
- Transplant cells to improve movement
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- iRegene Therapeutics Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 5 participants
- Conditions
- Parkinson Disease
- Interventions
- Human Dopaminergic Progenitor Cells
Summary For Families
The goal is to see if transplanting NouvNeu001 can be done safely, is tolerable and feasible, and shows early signs of benefit for people with advanced Parkinson's disease. The treatment places human cells that are meant to replace or support movement-related brain cells into both sides of a deep movement area using precise brain surgery, and participants will take immune-suppressing medicine for about 24 to 36 weeks to reduce rejection. Everyone in the study gets the transplant and is followed at multiple centers so researchers can watch safety and early effects. Eligible people are 30 to 75 years old, have had Parkinson's for 4 to 20 years with significant motor symptoms that still improve with levodopa, and must be medically fit for brain surgery; people with prior brain cell therapy or major unstable medical problems, dementia, active infections, or prior certain brain surgeries are excluded.
Locations
- Cornell University Weill Medical College, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Human Dopaminergic Progenitor Cells. The goal is to see if transplanting NouvNeu001 can be done safely, is tolerable and feasible, and shows early signs of benefit for people with advanced Parkinson's disease. The treatment places human cells that are meant to replace or support movement-related brain cells into both sides of a deep movement area using precise brain surgery, and participants will take immune-suppressing medicine for about 24 to 36 weeks to reduce rejection. Everyone in the study gets the transplant and is followed at multiple centers so researchers can watch safety and early effects. Eligible people are 30 to 75 years old, have had Parkinson's for 4 to 20 years with significant motor symptoms that still improve with levodopa, and must be medically fit for brain surgery; people with prior brain cell therapy or major unstable medical problems, dementia, active infections, or prior certain brain surgeries are excluded.
- Who can participate?
- Participants must be between 30 Years and 75 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/Phase 2 trial is estimated to last approximately 1 year and 8 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.
- How many visits does this trial involve?
- The study includes a 12-month follow-up period.
- 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.