Human induced pluripotent stem cel… for Parkinson's (NCT06482268)
Improve movement and reduce stiffness
- 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
- Improve movement and reduce stiffness
- 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)
Summary For Families
Researchers are testing whether transplanting lab-grown human stem cell, derived dopamine precursor cells into a movement-related part of the brain can be done safely and whether it improves Parkinson's symptoms or slows clinical progression, with close monitoring for side effects and any excessive growth of the transplant. The procedure places early-stage, dopamine-producing human cells into the corpus striatum so they might replace or support the brain cells lost in Parkinson's. The trial is looking for people aged 40 to 75 who have had Parkinson's for at least five years, have not had adequate relief from medicines but still get clear benefit from levodopa and have both on and off periods, and who meet other health and lab requirements and agree to avoid pregnancy; people with dementia, active infections, prior similar transplants, or certain brain surgeries are excluded.
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). Researchers are testing whether transplanting lab-grown human stem cell, derived dopamine precursor cells into a movement-related part of the brain can be done safely and whether it improves Parkinson's symptoms or slows clinical progression, with close monitoring for side effects and any excessive growth of the transplant. The procedure places early-stage, dopamine-producing human cells into the corpus striatum so they might replace or support the brain cells lost in Parkinson's. The trial is looking for people aged 40 to 75 who have had Parkinson's for at least five years, have not had adequate relief from medicines but still get clear benefit from levodopa and have both on and off periods, and who meet other health and lab requirements and agree to avoid pregnancy; people with dementia, active infections, prior similar transplants, or certain brain surgeries are excluded.
- 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?
- 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 trial is estimated to last approximately 9 months.
- 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?
- Everyone in this trial receives the experimental treatment. There is no placebo group.