Objective
The goal of this study was to evaluate the safety of bemdaneprocel and its effects on health outcomes for people with Parkinson’s disease (PD) over a period of 24 months following transplantation.
Background
Bemdaneprocel is a new treatment being tested for Parkinson’s disease. It uses special cells derived from human embryonic stem cells. Previous studies showed that it was safe and had potential benefits.
Study Design
This was a Phase 1 study involving 12 participants with Parkinson’s disease. They received either a low dose or a high dose of bemdaneprocel during a single surgery under general anesthesia. Participants were monitored for 24 months, starting with 12 months of immunosuppression treatment.
Results
All participants were around 67 years old, mostly male, and predominantly White. The average time since their PD diagnosis was 9 years. Over the 24 months, there were 89 side effects reported, mostly mild to moderate. Serious side effects included hospitalizations unrelated to the treatment. Importantly, no deaths or major complications occurred.
In the high-dose group, improvements were noted in clinical assessments related to Parkinson’s symptoms, while the low-dose group showed stability or slight improvement.
Conclusions
Bemdaneprocel showed a good safety profile and suggested potential benefits for participants over the 24-month period. All participants will continue to be monitored in a further study to better understand its effectiveness.
Next Steps
These findings support the ongoing development of bemdaneprocel in larger Phase 3 trials to further assess its safety and effectiveness for individuals with Parkinson’s disease.
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