Abstract
Objective
- To continue evaluating the safety and tolerability of bemdaneprocel through 24 months post transplantation, 12 months post discontinuation of immunosuppression, in participants with PD.
Methods
- Participants with PD, with motor symptoms inadequately controlled by standard treatments, and who were >=50 to <=78 years of age in Canada or >=60 to <=78 years of age in the United States were eligible to enroll in the study.
- 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.
- Unified Dyskinesia Rating Scale (UDysRS) observed scores and anti-Parkinson’s disease medication use (calculated as levodopa equivalent daily doses) were summarized at baseline and 6, 12, 18, and 24 months post transplantation.
Additional Safety Findings
- None of the 3 treatment-emergent serious adverse events were related to transplanted cells or immunosuppression, and there were no graft-induced dyskinesias.
- TEAEs in nervous system disorders and infections and infestations System Organ Classes were reported for 8/12 (66.7%) participants each.
- The most frequently reported treatment-emergent adverse events in the nervous system disorders System Organ Class (n=8, 66.7%) were dyskinesia (n=3, 25.0%) and tremor (n=2, 16.7%).
- The most frequently reported treatment-emergent adverse events in the infections and infestations System Organ Class (n=8, 66.7%) were COVID-19 (n=4, 33.3%) and pneumonia (n=2, 16.7%).
Conclusions
- Bemdaneprocel was well tolerated and had a favorable safety profile in all 12 participants through 24 months post transplantation, 12 months post discontinuation of immunosuppression.
- No serious adverse events were attributed to transplanted cells or immunosuppression, and there were no graft-induced dyskinesias, deaths, or study discontinuations.
- Anti-Parkinson’s disease medication use was stable, and there were no intracerebral hemorrhages or mass lesions.
- All participants have enrolled in a continued-evaluation study (NCT05897957) for ongoing evaluation of safety and efficacy.
- These results support the continued development of bemdaneprocel for the treatment of people with PD.
View references
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