Dopacell for Parkinson's (NCT07572071)
Studying Parkinson cell transplant safety
- 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
- Studying Parkinson cell transplant safety
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Royan Institute
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Parkinson Disease (PD)
- Interventions
- Dopacell, Immunosuppressive Regimen, Customized microinjection device
- Registry Record Last Updated
- 2026-06-18 (1 month ago)
- Estimated Commitment
- Higher commitment estimated from the protocol (based on: invasive procedure, 12 study visits). This reflects time and procedures only — confirm details with the study coordinator.
Summary For Families
Dopason tests whether transplanting DopaCells, cells made from human embryonic stem cells that are intended to become dopamine-producing brain cells, into the putamen can be done safely and feasibly for people with moderately severe Parkinson's disease. Each of six participants will have one standardized surgery to place about 10 million cells total, split between both sides of the brain, using the same delivery system at two sites, then take immune-suppressing medication for one year and be followed for at least 12 months, with the team aiming for roughly 200,000 surviving neurons. The trial is recruiting adults 30 to 70 years old who have had Parkinson's for more than five years at a moderate stage, who still respond to levodopa but whose symptoms are not well controlled or who have troublesome side effects, and who pass safety checks such as no dementia or certain brain injuries and the ability to take immune-suppressing drugs.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Hoehn and Yahr stage 2 to 3
- Levodopa: Must be taking levodopa (criteria text: "* the patient demonstrates a clinically meaningful response to a therapeutic dose of levodopa, as determined by the principal clinical investigator or a trai...")
- Motor fluctuations: Must have motor fluctuations (off periods when medication wears off) (criteria text: "* Moderate Parkinson's disease, defined as a Hoehn and Yahr stage of 2 or 3 during the OFF period.")
- Dyskinesia: Must have dyskinesia (involuntary movements) (criteria text: "* No history or only mild levodopa-induced dyskinesia, defined as a score of 2 or less on the UDysRS scale in any body region during the ON state.")
- Deep brain stimulation: Cannot join after DBS surgery (deep brain stimulation) (criteria text: "* history of pallidotomy, thalamotomy, or deep brain stimulation (dbs)")
- GBA gene: Cannot join with a GBA gene variant (criteria text: "* positive gba mutation test")
- Time since diagnosis: Diagnosed at least 5 years ago (criteria text: "inclusion criteria: * age: 30-70 years * diagnosis of pd: mds clinical diagnostic criteria for parkinson's disease * the disease duration more than 5 years *...")
- Thinking test (MoCA): MoCA memory and thinking score of at least 24 (criteria text: "* Diagnosis of dementia based on a MoCA score \< 24.")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people aged 30 to 70.
- This trial does not enroll people who have had (or are scheduled for) DBS surgery.
- This trial requires participants to be taking levodopa.
- This trial requires a Parkinson's diagnosis at least 5 years ago.
- This trial requires motor fluctuations (off periods).
- This trial requires dyskinesia (involuntary movements).
- This trial does not enroll people with a GBA gene variant.
Locations
- Shiraz University of Medical Sciences, Shiraz, Iran
- Iran University of Medical Sciences, Tehran, Iran
- Royan Institute, Tehran, Iran
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07572071. It is the one about "Studying Parkinson cell transplant safety". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: Each participant will have one surgical procedure and will be followed for at least 12 months. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: Everyone in this trial receives the experimental treatment. There is no placebo group. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Dopacell. Dopason tests whether transplanting DopaCells, cells made from human embryonic stem cells that are intended to become dopamine-producing brain cells, into the putamen can be done safely and feasibly for people with moderately severe Parkinson's disease. Each of six participants will have one standardized surgery to place about 10 million cells total, split between both sides of the brain, using the same delivery system at two sites, then take immune-suppressing medication for one year and be followed for at least 12 months, with the team aiming for roughly 200,000 surviving neurons. The trial is recruiting adults 30 to 70 years old who have had Parkinson's for more than five years at a moderate stage, who still respond to levodopa but whose symptoms are not well controlled or who have troublesome side effects, and who pass safety checks such as no dementia or certain brain injuries and the ability to take immune-suppressing drugs.
- 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?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; 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 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.