GM101 for Parkinson's (NCT07100171)
Gene therapy to reduce stiffness
- Trial ID
- NCT07100171
- Official Title
- A Single-Center, Open-Label, Single-Arm Exploratory Study Evaluating GM101 Injection in Patients With Mid-to-Late Stage Parkinson's Disease
- Goal
- Gene therapy to reduce stiffness
- Phase
- EARLY_PHASE1
- Status
- RECRUITING
- Sponsor
- Genemagic Biosciences Co., Ltd
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson's Disease
- Interventions
- Biological: GM101
Summary For Families
The goal is to see if GM101 is safe for people with mid-to-late-stage Parkinson's disease. GM101 is given by injection into a movement-related area of the brain called the putamen, using adeno-associated viruses to deliver a gene that aims to reprogram nearby support cells, called astrocytes, into dopamine-producing nerve cells. The trial seeks people aged 40 to 70 who have had Parkinson's for at least five years, have advanced symptoms when off medication but still improve with levodopa, are on a stable Parkinson's medicine regimen, and can undergo brain surgery and imaging; people with prior gene therapy or certain brain surgeries, active major health problems, or other disqualifying conditions are excluded.
Locations
- Xiangya Hospital, Central South University, Changsha, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Biological: GM101. The goal is to see if GM101 is safe for people with mid-to-late-stage Parkinson's disease. GM101 is given by injection into a movement-related area of the brain called the putamen, using adeno-associated viruses to deliver a gene that aims to reprogram nearby support cells, called astrocytes, into dopamine-producing nerve cells. The trial seeks people aged 40 to 70 who have had Parkinson's for at least five years, have advanced symptoms when off medication but still improve with levodopa, are on a stable Parkinson's medicine regimen, and can undergo brain surgery and imaging; people with prior gene therapy or certain brain surgeries, active major health problems, or other disqualifying conditions are excluded.
- Who can participate?
- Participants must be between 40 Years and 70 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 1 year and 9 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: MRI scan (non-invasive). Confirm the full schedule with the study coordinator.