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
Plain-Language Summary
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.