hiPSC-DAP for Parkinson's (NCT06145711)
Improve movement control through transplant
- 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
- Improve movement control through transplant
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Shanghai East Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 3 participants
- Conditions
- Parkinson's Disease
- Interventions
- hiPSC-DAP
Summary For Families
A team in Shanghai is testing whether transplanting each person’s own lab-grown stem cells, turned into early-stage dopamine-making brain cells, can be given safely and begin to help movement symptoms in Parkinson’s. Under general anesthesia, surgeons will use precise image-guided injections to place those cells into the putamen, a part of the brain that helps control movement, and a small monitoring device called a Sofia drug pouch will be used to track dopamine and related chemicals. They seek three people aged 30 to 70 who have had typical Parkinson’s for more than five years, are in moderate to advanced stages (usually stage 3 or 4), previously responded to levodopa but now have wearing-off, and are on stable Parkinson’s medications. Safety will be watched closely for at least six months, with each person followed for up to 12 months after one-side treatment or 24 months if both sides are treated.
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. A team in Shanghai is testing whether transplanting each person’s own lab-grown stem cells, turned into early-stage dopamine-making brain cells, can be given safely and begin to help movement symptoms in Parkinson’s. Under general anesthesia, surgeons will use precise image-guided injections to place those cells into the putamen, a part of the brain that helps control movement, and a small monitoring device called a Sofia drug pouch will be used to track dopamine and related chemicals. They seek three people aged 30 to 70 who have had typical Parkinson’s for more than five years, are in moderate to advanced stages (usually stage 3 or 4), previously responded to levodopa but now have wearing-off, and are on stable Parkinson’s medications. Safety will be watched closely for at least six months, with each person followed for up to 12 months after one-side treatment or 24 months if both sides are treated.
- 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?
- 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 trial is estimated to last approximately 2 years and 1 month.
- 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); Surgical procedure (invasive); Injection (minimally invasive). Confirm the full schedule with the study coordinator.