Dopacell for Parkinson's (NCT07572071)
Cell transplant improves movement symptoms
- Trial ID
- NCT07572071
- Official Title
- Evaluation of the Safety and Feasibility of a Single Transplantation of 10 Million Human Embryonic Stem Cell-Derived Dopaminergic Progenitor Cells Into the Bilateral Striatum of Patients With Moderately Severe Parkinson's Disease: a Multicenter, Open-label, Single-arm Phase I Clinical Trial
- Goal
- Cell transplant improves movement symptoms
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Royan Institute
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- Dopacell, Immunosuppressive Regimen, Customized microinjection device
Summary For Families
Researchers are testing whether placing human embryonic stem cell-derived cells that can become dopamine-producing brain cells into the movement-control part of the brain can be done safely in people with moderately severe Parkinson's. The treatment is given once by precise, image-guided brain surgery that injects about 10 million cells total, about 5 million into each side of the putamen, with the goal of an estimated survival of around 200,000 neurons; participants will take immunosuppressive medicine for one year and be followed for at least 12 months. The trial will enroll ten people aged 30 to 70 who have had Parkinson's for more than five years, have moderate symptoms that still respond to levodopa but are not well controlled by oral medications, and who pass standard safety tests like blood work and brain imaging. People with dementia, certain genetic mutations such as GBA, active infections, prior deep brain stimulation or other brain lesion surgery, or who cannot take immunosuppression are not eligible.
Locations
- Shiraz University of Medical Sciences, Shiraz, Iran
- Iran University of Medical Sciences, Tehran, Iran
- Royan Institute, Tehran, Iran
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Dopacell. Researchers are testing whether placing human embryonic stem cell-derived cells that can become dopamine-producing brain cells into the movement-control part of the brain can be done safely in people with moderately severe Parkinson's. The treatment is given once by precise, image-guided brain surgery that injects about 10 million cells total, about 5 million into each side of the putamen, with the goal of an estimated survival of around 200,000 neurons; participants will take immunosuppressive medicine for one year and be followed for at least 12 months. The trial will enroll ten people aged 30 to 70 who have had Parkinson's for more than five years, have moderate symptoms that still respond to levodopa but are not well controlled by oral medications, and who pass standard safety tests like blood work and brain imaging. People with dementia, certain genetic mutations such as GBA, active infections, prior deep brain stimulation or other brain lesion surgery, or who cannot take immunosuppression are not eligible.
- Who can participate?
- Participants must be between 30 Years and 70 Years.
- Where is this trial located?
- This trial is recruiting at 3 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 Phase 1 trial is estimated to last approximately 3 years.
- 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?
- Each participant will have one surgical procedure and will be followed for at least 12 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive). Confirm the full schedule with the study coordinator.