Transplant restores dopamine producing cells
- Trial ID
- NCT06482268
- Official Title
- An Investigator-initiated Clinical Trial of Safety and Efficacy of Transplantation of Human Induced Pluripotent Stem Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I/II)
- Goal
- Transplant restores dopamine producing cells
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- University of California, San Diego
- Study Type
- INTERVENTIONAL
- Enrollment
- 7 participants
- Conditions
- PD - Parkinson's Disease
- Interventions
- Human induced pluripotent stem cell-derived dopaminergic progenitors (CT1-DAP001)
Plain-Language Summary
The goal is to restore dopamine-producing cells in the brain to improve motor symptoms and reduce disabling OFF periods for people whose medications are no longer working well. The approach is a one-time surgical transplant of CT1-DAP001, dopaminergic progenitors made from human induced pluripotent stem cells that are intended to mature into dopamine-producing neurons and replace lost cells, and the grafts are given with immunosuppression; participants must be able to take levodopa because a clear levodopa response is required. As a Phase I/II trial the main focus is on safety and early signs of benefit rather than proving long-term effectiveness. Eligible people are ages 40 to 75, have had Parkinson's at least 5 years, experience ON and OFF periods, show at least a 30% improvement with levodopa, and meet specific health, lab, and MRI criteria.
Locations
- University of California, San Diego, La Jolla, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Human induced pluripotent stem cell-derived dopaminergic progenitors (CT1-DAP001). The goal is to restore dopamine-producing cells in the brain to improve motor symptoms and reduce disabling OFF periods for people whose medications are no longer working well. The approach is a one-time surgical transplant of CT1-DAP001, dopaminergic progenitors made from human induced pluripotent stem cells that are intended to mature into dopamine-producing neurons and replace lost cells, and the grafts are given with immunosuppression; participants must be able to take levodopa because a clear levodopa response is required. As a Phase I/II trial the main focus is on safety and early signs of benefit rather than proving long-term effectiveness. Eligible people are ages 40 to 75, have had Parkinson's at least 5 years, experience ON and OFF periods, show at least a 30% improvement with levodopa, and meet specific health, lab, and MRI criteria.
- Who can participate?
- Participants must be between 40 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 trial is estimated to last approximately 9 months.