Restore dopamine production in putamen
- Trial ID
- NCT07106021
- Official Title
- A Phase 1b/2a Study Assessing the Safety and Efficacy of Intraputamenal Dopaminergic Stem Cell Transplants in Patients With Idiopathic Parkinson's Disease
- Goal
- Restore dopamine production in putamen
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- Kenai Therapeutics
- Study Type
- INTERVENTIONAL
- Enrollment
- 12 participants
- Conditions
- Idiopathic Parkinson´s Disease, Parkinson's Disease
- Interventions
- RNDP-001, Syringe Front-Loading Device
Summary For Families
The goal is to replace the dopamine-making cells lost in Parkinson's by putting new dopaminergic stem cells into the putamen, hoping to improve motor symptoms and eventually reduce reliance on levodopa. The treatment, called RNDP-001, is a stem cell product delivered surgically with a syringe front-loading device so the new cells can produce dopamine locally rather than changing how levodopa works; the trial is focused on early safety and signals of benefit while people may remain on their usual medications. Eligible participants are adults 45 to 75 with idiopathic Parkinson's who are medically stable for brain surgery; people with known Parkinson's gene mutations, prior Parkinson's surgeries or infusion therapies, MRI contraindications, or significant medical problems are excluded. The trial is a small, early-phase study planning to enroll about 12 participants.
Locations
- University of Arizona, Tucson, Arizona, United States
- Keck Medical Center of University of Southern California, Los Angeles, California, United States
- The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying RNDP-001. The goal is to replace the dopamine-making cells lost in Parkinson's by putting new dopaminergic stem cells into the putamen, hoping to improve motor symptoms and eventually reduce reliance on levodopa. The treatment, called RNDP-001, is a stem cell product delivered surgically with a syringe front-loading device so the new cells can produce dopamine locally rather than changing how levodopa works; the trial is focused on early safety and signals of benefit while people may remain on their usual medications. Eligible participants are adults 45 to 75 with idiopathic Parkinson's who are medically stable for brain surgery; people with known Parkinson's gene mutations, prior Parkinson's surgeries or infusion therapies, MRI contraindications, or significant medical problems are excluded. The trial is a small, early-phase study planning to enroll about 12 participants.
- Who can participate?
- Participants must be between 45 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 3 locations.
- 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 Phase 1/Phase 2 trial is estimated to last approximately 2 years and 1 month.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.