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
Plain-Language Summary
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?
- 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 6 years.