DSP-1083 implantation for Parkinson's (NCT06753331)
Restore dopamine to improve movement
- Trial ID
- NCT06753331
- Official Title
- A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses Following Stereotactic Intracranial Implantation of DSP-1083 Into Subjects With Parkinson's Disease
- Goal
- Restore dopamine to improve movement
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- Sumitomo Pharma America, Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 25 participants
- Conditions
- Parkinson's Disease
- Interventions
- DSP-1083 implantation, Sham surgery treatment
Summary For Families
The goal is to test whether implanting DSP-1083 cells into movement-related brain areas can safely engraft and improve motor symptoms by restoring dopamine function in people whose Parkinson's is not well controlled on meds. The approach is stereotactic brain surgery to place a cell therapy product, with a randomized sham surgery control so researchers can compare safety and clinical responses; the implanted cells are intended to survive and replace or support dopamine-producing neurons while participants remain on their usual levodopa regimen so changes in medication response can be assessed. The trial is looking for adults 40 to 72 years old with a clinical PD diagnosis for at least 4 years, a clear levodopa response, suboptimal control despite stable levodopa-based therapy, moderate off-state disability, and no prior DBS, ablation, or other implanted brain therapies.
Locations
- University of Kentucky Medical Center, Lexington, Kentucky, United States
- New York Presbyterian Hospital-Columbia University Medical Center, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying DSP-1083 implantation. The goal is to test whether implanting DSP-1083 cells into movement-related brain areas can safely engraft and improve motor symptoms by restoring dopamine function in people whose Parkinson's is not well controlled on meds. The approach is stereotactic brain surgery to place a cell therapy product, with a randomized sham surgery control so researchers can compare safety and clinical responses; the implanted cells are intended to survive and replace or support dopamine-producing neurons while participants remain on their usual levodopa regimen so changes in medication response can be assessed. The trial is looking for adults 40 to 72 years old with a clinical PD diagnosis for at least 4 years, a clear levodopa response, suboptimal control despite stable levodopa-based therapy, moderate off-state disability, and no prior DBS, ablation, or other implanted brain therapies.
- Who can participate?
- Participants must be between 40 Years and 72 Years.
- Where is this trial located?
- This trial is recruiting at 2 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 6 years.
- 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 trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- 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.