Clinical Research Directory

A Phase 1 Study of NCR201 in Parkinson's Disease Patients With Prior DBS

This is a Phase 1 clinical trial to evaluate the safety and tolerability of a new cell therapy called NCR201. The study will enroll adults with moderate-to-advanced primary Parkinson's disease who have previously undergone deep brain stimulation (DBS) surgery. NCR201 is an investigational cell therapy derived from hypoimmune human induced pluripotent stem cells (iPSCs). Participants will receive a one-time surgical injection of NCR201 directly into a specific brain region (the putamen) on both sides. The study will use a standard "3+3" design to test two different doses: a low-dose group (4 million cells per side) and a high-dose group (8 million cells per side). The primary goal of this study is to check for any severe, dose-limiting side effects within the first 8 weeks after surgery, and to determine the maximum tolerated dose or the recommended dose for future Phase 2 studies. Researchers will also look for any initial signs of clinical benefit. Participants will be closely monitored through regular safety and symptom assessments for up to 96 weeks, with an optional long-term safety follow-up lasting an additional 3 to 5 years.