Phase I Study of Safety and Feasibility of Transplanting 10 Million Human Embryonic Stem Cell-Derived Dopaminergic Cells into Both Sides of the Brain in Moderate Parkinsons Disease

What this Trial Is About

Researchers are evaluating the safety and feasibility of transplanting human embryonic stem cell-derived dopaminergic progenitor cells, called DopaCells, directly into the brains of patients with moderately severe Parkinsons disease. This phase I, open-label, multicenter trial aims to assess how well this approach can be performed and its safety profile in a small group of participants. Participants will receive a one-time surgical procedure where about 10 million DopaCells are transplanted bilaterally into the putamen region of the brain using a specialized microinjection device. After the surgery, patients will undergo immunosuppressive therapy with drugs including Basiliximab, Tacrolimus, and Prednisolone for one year to support cell survival. The study will be conducted across two centers with consistent surgical and treatment protocols. Participants will be monitored closely for at least 12 months after transplantation to evaluate safety and feasibility outcomes. This includes regular clinical assessments, laboratory tests, and imaging to track treatment effects and potential side effects. The research team will also assess efficacy outcomes and continue safety monitoring up to 60 months post-transplant. The total participant involvement includes screening, surgery, immunosuppressive therapy, and long-term follow-up under medical supervision.

Safety and Feasibility of Bilateral Striatal Transplantation of DopaCell in Parkinson's Disease