RNDP-001 for Parkinson's (NCT07106021)
Stem cell surgery improves walking
- 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
- Stem cell surgery improves walking
- 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 check whether a new stem cell transplant placed into a deep brain area called the putamen is safe and well tolerated in people with idiopathic Parkinson's disease. The approach uses a surgical procedure to implant stem cells meant to become dopamine-producing brain cells, delivered into the putamen with a specially designed syringe device, and the study watches how people do after the operation. They are looking for adults aged 45 to 75 with idiopathic Parkinson's who are medically stable for surgery; people with known Parkinson's gene mutations, prior infusion therapy or Parkinson's surgery, allergy to immune therapies, inability to have magnetic resonance imaging, or other serious medical problems are not eligible.
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 check whether a new stem cell transplant placed into a deep brain area called the putamen is safe and well tolerated in people with idiopathic Parkinson's disease. The approach uses a surgical procedure to implant stem cells meant to become dopamine-producing brain cells, delivered into the putamen with a specially designed syringe device, and the study watches how people do after the operation. They are looking for adults aged 45 to 75 with idiopathic Parkinson's who are medically stable for surgery; people with known Parkinson's gene mutations, prior infusion therapy or Parkinson's surgery, allergy to immune therapies, inability to have magnetic resonance imaging, or other serious medical problems are not eligible.
- 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?
- 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/Phase 2 trial is estimated to last approximately 2 years and 1 month.
- 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Surgical procedure (invasive). Confirm the full schedule with the study coordinator.