Human Dopaminergic Progenitor Cells for Parkinson's (NCT07102342)
Transplant cells to improve movement
- Trial ID
- NCT07102342
- Official Title
- A Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Feasibility, and Preliminary Efficacy of NouvNeu001 in Patients With Advanced Parkinson's Disease.
- Goal
- Transplant cells to improve movement
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- iRegene Therapeutics Co., Ltd.
- Study Type
- INTERVENTIONAL
- Enrollment
- 5 participants
- Conditions
- Parkinson Disease
- Interventions
- Human Dopaminergic Progenitor Cells
- Registry Record Last Updated
- 2026-05-11 (2 months ago)
- Estimated Commitment
- Moderate commitment estimated from the protocol (based on: invasive procedure). This reflects time and procedures only — confirm details with the study coordinator.
Summary For Families
The goal is to see if transplanting NouvNeu001 can be done safely, is tolerable and feasible, and shows early signs of benefit for people with advanced Parkinson's disease. The treatment places human cells that are meant to replace or support movement-related brain cells into both sides of a deep movement area using precise brain surgery, and participants will take immune-suppressing medicine for about 24 to 36 weeks to reduce rejection. Everyone in the study gets the transplant and is followed at multiple centers so researchers can watch safety and early effects. Eligible people are 30 to 75 years old, have had Parkinson's for 4 to 20 years with significant motor symptoms that still improve with levodopa, and must be medically fit for brain surgery; people with prior brain cell therapy or major unstable medical problems, dementia, active infections, or prior certain brain surgeries are excluded.
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.
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "* Patients who take stable doing of dopamine drug for at least 4 weeks prior to receiving the study drug.")
- Motor fluctuations: Must have motor fluctuations (off periods when medication wears off) (criteria text: "* H-Y staging (Appendix III) for "OFF" episodes is 2.5-4.0.")
- Dyskinesia: Cannot join with significant dyskinesia (involuntary movements) (criteria text: "men who are not surgically sterilized/unwilling to use medically approved effective contraception during the study * patients who have received electric shoc...")
- Deep brain stimulation: Cannot join after DBS surgery (deep brain stimulation) (criteria text: "exclusion criteria: medical conditions * atypical parkinsonism (parkinsonism-plus syndrome, secondary parkinsonism, familial parkinsonism) prior/concomitant ...")
- Time since diagnosis: Diagnosed between 4 years and 20 years ago (criteria text: "* Diagnosis of PD between past 4 to 20 years (meet MDS 2015 clinical diagnostic criteria for PD).")
- Movement score (MDS-UPDRS): MDS-UPDRS movement score of at least 36 (criteria text: "* mds-updrs-iii score > 35, and positive for the acute levodopa challenge test (alct) (improvement > 30% for mds updrs-iii staging from off episodes to on ep...")
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 75.
- This trial does not enroll people who have had (or are scheduled for) DBS surgery.
- This trial requires a Parkinson's diagnosis between 4 years and 20 years ago.
- This trial requires motor fluctuations (off periods).
- This trial does not enroll people with significant dyskinesia.
Locations
- Cornell University Weill Medical College, New York, New York, United States
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 NCT07102342. It is the one about "Transplant cells to improve movement". 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?
- 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 Human Dopaminergic Progenitor Cells. The goal is to see if transplanting NouvNeu001 can be done safely, is tolerable and feasible, and shows early signs of benefit for people with advanced Parkinson's disease. The treatment places human cells that are meant to replace or support movement-related brain cells into both sides of a deep movement area using precise brain surgery, and participants will take immune-suppressing medicine for about 24 to 36 weeks to reduce rejection. Everyone in the study gets the transplant and is followed at multiple centers so researchers can watch safety and early effects. Eligible people are 30 to 75 years old, have had Parkinson's for 4 to 20 years with significant motor symptoms that still improve with levodopa, and must be medically fit for brain surgery; people with prior brain cell therapy or major unstable medical problems, dementia, active infections, or prior certain brain surgeries are excluded.
- Who can participate?
- Participants must be between 30 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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/Phase 2 trial is estimated to last approximately 1 year and 8 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Injection (minimally invasive). Confirm the full schedule with the study coordinator.