Treating Parkinson's Disease Through Transplantation of Autologous Stem Cell-Derived Dopaminergic Neurons
Trial Parameters
Brief Summary
The goal of this clinical trial is to assess the safety and tolerability of the surgical transplantation of dopaminergic progenitor cells into the brains of participants with Parkinson's disease. The transplanted dopaminergic cells will be derived from the participant's own skin cells.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Parkinson's Disease consistent with the Movement Disorders Society 2015 Parkinson's diagnostic criteria. * Age 45 - 80 years * English proficiency sufficient to understand the consent form and participate in a discussion of risks and benefits * At least 5 years since Parkinson's disease motor symptom onset * Modified Hoehn and Yahr stage 3-4 in "off"-medication state * Motor symptoms responsive to levodopa and/or dopamine agonist, defined as taking at least 300 mg/day of levodopa and exhibiting improvement between "off" and "on" MDS-UPDRS of at least 30% * At least 3 hours of cumulative "off" time per day * Stable regimen of Parkinson's medications, including levodopa and dopamine agonists, for at least 4 weeks prior to screening. * Acceptable surgical laboratory values including: 1. Platelets \> 100×109/L (transfusion independent) 2. Prothrombin time / partial thromboplastin time in normal range and international normalized ratio ≤ 1.3 3. Aspartate a