Safety and Effectiveness Study of Human iPS Cell-derived Dopaminergic Progenitor Transplantation CT1-DAP001 for Parkinsons Disease in Adults Aged 40 to 75

What this Trial Is About

Researchers are evaluating the safety and effectiveness of transplanting human induced pluripotent stem cell-derived dopaminergic progenitors, called CT1-DAP001, into the brain region called the corpus striatum in people with Parkinsons disease. This open-label, uncontrolled phase III study aims primarily to assess possible side effects, especially graft expansion, and also to observe changes in Parkinsons symptoms and disease progression. Participants will receive the investigational CT1-DAP001 cells transplanted into the putamen using a specialized cell injector attached to a stereotactic frame. PET agents are also used according to institutional guidelines to assist in the procedure. The study is conducted at a single center and does not involve comparison groups or placebo. The transplantation is carefully managed with close monitoring. During the 24-month study period, participants will undergo evaluations for safety and acceptability, including monitoring adverse events. Researchers will assess quality of life, Parkinsons symptom scores MDS-UPDRS Part III at ON and OFF times, daily ON and OFF durations, and medication doses. Participants will follow protocol-required assessments and laboratory tests, with attention to organ function and disease status throughout the study.

Transplantation of Human iPS Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I/II)