Abstract
Objective
- To report safety and clinical outcomes of the Continued Evaluation Study participants with PD through 4 years after bemdaneprocel administration
Methods
- In exPDite, 12 participants with PD enrolled and completed the exPDite trial across centers in the USA and Canada to receive either low- or high-dose bemdaneprocel, sequentially; all 12 participants subsequently enrolled in a Continued Evaluation Study (Figure 1) for assessment through 5 years
- Bemdaneprocel was administered stereotactically into the posterior putamen bilaterally through a single burr hole on each side in a single session (Figure 2), with a 1-year immunosuppression regimen initiated during transplantation
Conclusions
- Bemdaneprocel continued to demonstrate a favorable safety profile through 4 years; there were no deaths, or discontinuations due to TEAEs
- Motor outcomes demonstrated sustained favorable effects compared with baseline through 4 years
- F-DOPA PET findings supported durable dopaminergic signal preservation in the posterior putamen, while caudate uptake continued to decline through 3 years
- These data should be interpreted carefully given the small study population and open-label design
- The efficacy and safety of bemdaneprocel is being evaluated further in exPDite-2 (NCT06944522), a Phase 3, randomized, simulated, surgery-controlled, double-blind trial in approximately 102 participants with PD aged 45–75 years with motor symptoms inadequately controlled by standard treatments
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