Long-Term Safety and Effectiveness Study of IPS101A Gene Therapy in Severe Parkinsons Disease Patients from the IPS101A-10 Trial

What this Trial Is About

This research aims to evaluate the long-term safety and lasting effects of the IPS101A gene therapy product in people with severe Parkinsons disease who previously received this treatment in the IPS101A-10 clinical trial. The focus is on monitoring how well the treatment continues to work and checking for any safety concerns over several years. Participants in this follow-up study are those who received IPS101A in the earlier trial. The study involves observing these individuals without administering new treatments. Researchers will monitor health changes and the ongoing impact of the gene therapy over a five-year period. During the study, participants will undergo assessments to track serious adverse events, physical exam changes, and laboratory test results from baseline through five years. Movement symptoms will also be evaluated using a standardized Parkinsons disease rating scale. The study lasts up to five years, allowing researchers to gather comprehensive safety and efficacy data over time.

A Long-Term Follow-up Study of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product.