IPS101A for Parkinson's (NCT07371338)
Find safe gene therapy dose
- Trial ID
- NCT07371338
- Official Title
- Dose-Escalation, Single-Center, Open-label Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Adeno-associated Virus(AAV) Gene Therapy Product IPS101A in Parkinson's Disease Patients With Hoehn-Yahr Stage 4-5, Diagnosed in More Than 10 Years and Uncontrolled by All Available Monotherapy or Combination Therapy
- Goal
- Find safe gene therapy dose
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Innopeutics Corporation
- Study Type
- INTERVENTIONAL
- Enrollment
- 6 participants
- Conditions
- Parkinson Disease, Parkinson's Disease
- Interventions
- IPS101A
- Registry Record Last Updated
- 2026-04-21 (3 months ago)
- Estimated Commitment
- Commitment level unclear from the registry data — ask the study coordinator what taking part involves.
Summary For Families
The goal is to test different doses of a new gene therapy given with an adeno-associated virus to see how safe and tolerable it is in people with very advanced Parkinson's, to find the highest dose people can tolerate, and to collect early signs of benefit and information on how the body handles the treatment. The approach is a gene therapy product delivered using an adeno-associated virus, and the study will carefully monitor side effects, early effectiveness, and how the therapy moves through the body. They are looking for people aged 50 to 80 who have had Parkinson's for at least 10 years and who have severe disability (stage 4 or 5) not controlled by standard treatments; people with Parkinson's disease dementia, low cognitive test scores, certain scan findings suggesting other conditions, major visual hallucinations, or drug-induced parkinsonism 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.
- Time since diagnosis: Diagnosed at least 10 years ago (criteria text: "subjects with a duration of parkinson's disease of at least 10 years prior to the screening visit, based on medical history and/or medical records")
- Thinking test (MMSE): MMSE memory and thinking score of at least 24 (criteria text: "Subjects with a Korean Mini-Mental State Examination (K-MMSE) score ≤ 24 at the Screening assessment.")
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 50 to 80.
- This trial requires a Parkinson's diagnosis at least 10 years ago.
- This trial requires an MMSE thinking-test score of at least 24.
Locations
- Severance Hospital, Seoul, South Korea
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 NCT07371338. It is the one about "Find safe gene therapy dose". 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: There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another. 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 IPS101A. The goal is to test different doses of a new gene therapy given with an adeno-associated virus to see how safe and tolerable it is in people with very advanced Parkinson's, to find the highest dose people can tolerate, and to collect early signs of benefit and information on how the body handles the treatment. The approach is a gene therapy product delivered using an adeno-associated virus, and the study will carefully monitor side effects, early effectiveness, and how the therapy moves through the body. They are looking for people aged 50 to 80 who have had Parkinson's for at least 10 years and who have severe disability (stage 4 or 5) not controlled by standard treatments; people with Parkinson's disease dementia, low cognitive test scores, certain scan findings suggesting other conditions, major visual hallucinations, or drug-induced parkinsonism are excluded.
- Who can participate?
- Participants must be between 50 Years and 80 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 trial is estimated to last approximately 1 year and 5 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.