Evaluating Safety and Effects of DSP-1083 Cell Implants in Parkinsons Disease Patients Aged 40 to 72

What this Trial Is About

Researchers are studying the safety, tolerability, and clinical responses of DSP-1083 implantation in people with Parkinsons disease. This multicenter, first-in-human study compares the effects of dopaminergic progenitor cells derived from induced pluripotent stem cells DSP-1083 against sham surgery. The study evaluates safety through monitoring adverse events, changes in neuropsychiatric and cognitive status, and neuroimaging over a period of 104 weeks. Participants are randomly assigned to receive either DSP-1083 implants 2.7 million viable cells per hemisphere, totaling 5.4 million cells or undergo a sham surgery involving partial thickness burr hole procedures without cell implantation. The first sentinel subject undergoes two unilateral surgeries about 28 weeks apart, while other subjects receive one bilateral surgery. The trial is quadruple-masked and conducted at multiple sites in the United States. During the study, participants will have regular assessments including clinical evaluations, cognition tests like the Montreal Cognitive Assessment and Mattis Dementia Rating Scale, and brain imaging such as MRI and fluorodopa uptake scans to monitor graft function and safety. Researchers will also track vital signs, laboratory tests, and any adverse events for up to 104 weeks. The study aims to understand how DSP-1083 affects Parkinsons symptoms and safety over two years.

A Multicenter Study to Evaluate Safety, Tolerability, and Clinical Responses of DSP-1083 Into Subjects With Parkinson's Disease