Allogeneic dopaminergic neural pre… for Parkinson's (NCT06978920)
Reduce tremor with donor cells
- Trial ID
- NCT06978920
- Official Title
- A Phase I, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Dopaminergic Progenitor Cells (NCR201) Injection in the Treatment of Subjects With Parkinson's Disease
- Goal
- Reduce tremor with donor cells
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 48 participants
- Conditions
- Parkinson Disease
- Interventions
- Allogeneic dopaminergic neural precursor cell(NCR201)
Summary For Families
Goal: To find out whether injecting donor-derived, lab-grown precursor brain cells is safe, tolerable, and shows early signs of benefit for people with Parkinson's disease. The approach gives an injection of precursor cells made from stem cells, cells related to the brain cells that make dopamine, and the study will closely watch for side effects and any changes in symptoms. Who can join: adults 40 to 75 years old with Parkinson's for more than five years who are on a stable dose of dopamine medication and can have brain scans such as positron emission tomography, computed tomography, or magnetic resonance imaging; people with prior brain surgery, prior stem cell treatment, major memory or mental health problems, serious other illnesses, or cancer are not eligible.
Locations
- The First Affiliated Hospital of USTC, Hefei, Anhui, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Allogeneic dopaminergic neural precursor cell(NCR201). Goal: To find out whether injecting donor-derived, lab-grown precursor brain cells is safe, tolerable, and shows early signs of benefit for people with Parkinson's disease. The approach gives an injection of precursor cells made from stem cells, cells related to the brain cells that make dopamine, and the study will closely watch for side effects and any changes in symptoms. Who can join: adults 40 to 75 years old with Parkinson's for more than five years who are on a stable dose of dopamine medication and can have brain scans such as positron emission tomography, computed tomography, or magnetic resonance imaging; people with prior brain surgery, prior stem cell treatment, major memory or mental health problems, serious other illnesses, or cancer are not eligible.
- Who can participate?
- Participants must be between 40 Years and 75 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 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.