Reduce medication wearing off symptoms
- Trial ID
- NCT06145711
- Official Title
- A Clinical Trial of Parkinson's Disease Treatment by Human-induced Pluripotent Stem Cells (hiPSCs) Derived Dopaminergic Neural Precursor Cells
- Goal
- Reduce medication wearing off symptoms
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Shanghai East Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 3 participants
- Conditions
- Parkinson's Disease
- Interventions
- hiPSC-DAP
Summary For Families
It aims to replace the dopamine-producing cells lost in Parkinson's to reduce severe motor symptoms and the levodopa wearing-off that no longer responds well to medication. Surgeons inject dopaminergic neural precursor cells made from human-induced pluripotent stem cells into targeted brain areas using stereotactic surgery, the transplanted cells are intended to mature into dopamine neurons and supply a steadier source of dopamine, potentially lowering reliance on levodopa and smoothing motor fluctuations. Looking for adults 30 to 70 years old with primary Parkinson's for more than 5 years, mostly moderate to advanced disease (Hohen‑Yahr stage 3,4), clear and stable OFF-period motor scores, prior benefit then wearing-off on levodopa, stable meds for 3+ months, and the ability to undergo brain surgery with a caregiver to help.
Locations
- Shanghai East Hospital, Shanghai, Shanghai Municipality, China
- Shanghai East Hospital, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying hiPSC-DAP. It aims to replace the dopamine-producing cells lost in Parkinson's to reduce severe motor symptoms and the levodopa wearing-off that no longer responds well to medication. Surgeons inject dopaminergic neural precursor cells made from human-induced pluripotent stem cells into targeted brain areas using stereotactic surgery, the transplanted cells are intended to mature into dopamine neurons and supply a steadier source of dopamine, potentially lowering reliance on levodopa and smoothing motor fluctuations. Looking for adults 30 to 70 years old with primary Parkinson's for more than 5 years, mostly moderate to advanced disease (Hohen‑Yahr stage 3,4), clear and stable OFF-period motor scores, prior benefit then wearing-off on levodopa, stable meds for 3+ months, and the ability to undergo brain surgery with a caregiver to help.
- Who can participate?
- Participants must be between 30 Years and 70 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 trial is estimated to last approximately 2 years and 1 month.
- 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.