Autologous induced neural stem cel… for Parkinson's (NCT05901818)
Replace lost dopamine producing cells
- Trial ID
- NCT05901818
- Official Title
- Safety and Efficacy of Autologous Induced Neural Stem Cell-derived Dopaminergic Precursor Cells in the Treatment of Parkinson's Disease
- Goal
- Replace lost dopamine producing cells
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Xuanwu Hospital, Beijing
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Parkinson's Disease
- Interventions
- Autologous induced neural stem cell-derived DA precursor cells
Summary For Families
The goal is to test whether putting a patient’s own reprogrammed precursor cells that can become dopamine-producing brain cells into a movement-related brain area is safe and can help Parkinson’s symptoms. The team takes a sample of your blood, turns certain blood cells into neural stem cells, guides them into dopamine-producing precursor cells, and then injects those cells into the striatum using a precise, image-guided procedure; they will watch safety, tolerability, cell survival with PET brain scans, and symptom changes for up to 12 months. This small phase 1 study plans to enroll about 10 people aged 30 to 85 who have had Parkinson’s more than 3 years and who still get at least 30% improvement in movement after taking levodopa. People with atypical or secondary Parkinsonism, other major brain or medical problems, serious psychiatric illness, significant memory loss, severe involuntary movements, prior brain surgery, or who cannot have MRI or PET scans are not eligible.
Locations
- Xuanwu Hospital Capital Medical University, Beijing, Beijing Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Autologous induced neural stem cell-derived DA precursor cells. The goal is to test whether putting a patient’s own reprogrammed precursor cells that can become dopamine-producing brain cells into a movement-related brain area is safe and can help Parkinson’s symptoms. The team takes a sample of your blood, turns certain blood cells into neural stem cells, guides them into dopamine-producing precursor cells, and then injects those cells into the striatum using a precise, image-guided procedure; they will watch safety, tolerability, cell survival with PET brain scans, and symptom changes for up to 12 months. This small phase 1 study plans to enroll about 10 people aged 30 to 85 who have had Parkinson’s more than 3 years and who still get at least 30% improvement in movement after taking levodopa. People with atypical or secondary Parkinsonism, other major brain or medical problems, serious psychiatric illness, significant memory loss, severe involuntary movements, prior brain surgery, or who cannot have MRI or PET scans are not eligible.
- Who can participate?
- Participants must be between 30 Years and 85 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 6 years and 9 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?
- Study safety and symptom assessments will be done at multiple time points for up to 12 months after the transplantation.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Injection (minimally invasive); PET scan (minimally invasive). Confirm the full schedule with the study coordinator.