Parkinson's Trial NCT07629115
Evaluate long term gene therapy
- Trial ID
- NCT07629115
- Official Title
- A Long-Term Follow-up Study to Evaluate the Safety and Efficacy of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product in the IPS101A-10 Phase I Clinical Trial
- Goal
- Evaluate long term gene therapy
- Status
- RECRUITING
- Sponsor
- Innopeutics Corporation
- Study Type
- OBSERVATIONAL
- Enrollment
- 6 participants
- Conditions
- Parkinson Disease, Parkinson's Disease
Summary For Families
Goal: To check the long-term safety of IPS101A and to see whether any benefits people experienced after getting the gene therapy last over time. Approach: The study follows people who took part in the earlier IPS101A-10 trial and received the IPS101A gene therapy, with scheduled visits to monitor health and the durability of any effects. Eligibility: The study plans to include six people ages 50 to 80 who were in that earlier trial and received IPS101A, who can give written consent or have a family member or legal representative consent for them; people who decline, cannot complete follow up, or who have died are not included.
Locations
- Severance Hospital, Seoul, South Korea
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. Goal: To check the long-term safety of IPS101A and to see whether any benefits people experienced after getting the gene therapy last over time. Approach: The study follows people who took part in the earlier IPS101A-10 trial and received the IPS101A gene therapy, with scheduled visits to monitor health and the durability of any effects. Eligibility: The study plans to include six people ages 50 to 80 who were in that earlier trial and received IPS101A, who can give written consent or have a family member or legal representative consent for them; people who decline, cannot complete follow up, or who have died are not included.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 5 years and 2 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?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.