Phase 3 Randomized Study of Bemdaneprocel Cell Therapy Compared to Sham Surgery in Adults Aged 45 to 75 with Parkinsons Disease

What this Trial Is About

Researchers are evaluating the efficacy and safety of bemdaneprocel, an investigational cell therapy made from midbrain dopaminergic neuron progenitors derived from human embryonic stem cells, in adults aged 45 to 75 with Parkinsons Disease PD. This Phase 3, multicenter, randomized, sham surgery-controlled, double-blind study involves approximately 102 participants. The primary goal is to assess the effect of bemdaneprocel on motor symptoms, with additional goals including evaluating quality of life, non-motor symptoms, disease severity, and medication use compared to sham surgery. Participants will be randomly assigned in a 21 ratio to receive either bemdaneprocel treatment or undergo sham surgery on Day 0. Both groups will follow an immunosuppression regimen and receive placebo equivalents to maintain blinding. The double-blind period lasts at least 18 months, with those receiving bemdaneprocel followed for up to five years to monitor long-term effects. During the study, participants will undergo assessments including PD diary measures of ON-time and OFF-time, Movement Disorder Society-Unified Parkinsons Disease Rating Scale MDS-UPDRS scores, and the Parkinsons Disease Questionnaire-39 PDQ-39 to evaluate symptoms and quality of life. Safety will be monitored throughout, including tracking adverse events. The total study duration allows for ongoing evaluation of motor function and disease progression over several years.

A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease