Abstract
Objective
- To evaluate the impact of bemdaneprocel, compared with baseline, on non-motor outcomes up to 18 months post transplantation (6 months post discontinuation of immunosuppression) in participants with PD.
Methods
- Participants with PD motor symptoms inadequately controlled by standard treatments were >=50 to <=78 years of age in Canada or >=60 to <=78 years of age in the United States.
- A total of 12 participants enrolled sequentially.
- Bemdaneprocel was administered stereotactically into the posterior putamen bilaterally through a single burr hole on each side in a single session.
- Immunosuppression was initiated during transplantation and continued for 1 year post transplantation.
- Exploratory non-motor outcomes are reported as mean scores at baseline and 18 months post transplantation on the Parkinson’s Disease Non-Motor Symptom Scale (PD NMSS) and 39-item Parkinson’s Disease Questionnaire (PDQ-39).
Conclusions
- Participants who received bemdaneprocel experienced stability or improvement in many exploratory non-motor, quality of life, and psychiatric outcomes.
- Participants in the high-dose cohort showed greater trends towards improvement on the NPI-Q, RBANS, and FrSBe at 12 months, suggesting positive outcomes in neuropsychiatric symptoms, cognitive functioning, and frontal lobe-related behaviors.
- The high-dose cohort demonstrated stability of PD NMSS and PDQ-39 scores at 18 months (6 months post discontinuation of immunosuppression), suggesting controlled non-motor symptom severity and health-related quality of life.
- Trends in these data must be interpreted with caution due to the small sample size and uncontrolled study design.
- These results support the continued development of bemdaneprocel for the treatment of people with Parkinson’s disease and the continued investigation of the impact of bemdaneprocel on non-motor outcomes.
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