autologous dopaminergic cell impla… for Parkinson's (NCT06687837)
Restore dopamine producing brain cells
- Trial ID
- NCT06687837
- Official Title
- Phase I Trial of Autologous Induced Pluripotent Stem Cell-derived Dopaminergic Progenitor Cell Transplantation for Parkinson's Disease
- Goal
- Restore dopamine producing brain cells
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Jeffrey S. Schweitzer, MD, PhD
- Study Type
- INTERVENTIONAL
- Enrollment
- 8 participants
- Conditions
- Parkinson Disease
- Interventions
- autologous dopaminergic cell implantation
Summary For Families
The goal is to see whether surgically transplanting a person’s own skin cells, reprogrammed into early-stage dopamine-producing brain cells, is safe and well tolerated when placed into the brain of people with Parkinson's disease. For each participant, a skin sample will be turned into midbrain dopamine-producing cells and implanted on both sides of a movement-related brain area called the putamen under general anesthesia, with safety tracked by exams and imaging (CT, magnetic resonance imaging, and a PET scan that looks at dopamine) over two years. The trial seeks adults 45 to 80 who have had Parkinson's motor symptoms for at least five years, have moderate disease that still responds to levodopa, experience at least three hours of daily "off" time, and meet imaging and lab checks; people with dementia, certain genetic forms of Parkinson's, severe involuntary movements, or prior brain surgery are excluded.
Locations
- Massachusetts General Hospital, Boston, Massachusetts, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying autologous dopaminergic cell implantation. The goal is to see whether surgically transplanting a person’s own skin cells, reprogrammed into early-stage dopamine-producing brain cells, is safe and well tolerated when placed into the brain of people with Parkinson's disease. For each participant, a skin sample will be turned into midbrain dopamine-producing cells and implanted on both sides of a movement-related brain area called the putamen under general anesthesia, with safety tracked by exams and imaging (CT, magnetic resonance imaging, and a PET scan that looks at dopamine) over two years. The trial seeks adults 45 to 80 who have had Parkinson's motor symptoms for at least five years, have moderate disease that still responds to levodopa, experience at least three hours of daily "off" time, and meet imaging and lab checks; people with dementia, certain genetic forms of Parkinson's, severe involuntary movements, or prior brain surgery are excluded.
- Who can participate?
- Participants must be between 45 Years and 80 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 2 years and 7 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?
- 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: MRI scan (non-invasive). Confirm the full schedule with the study coordinator.